Women's Sexual Health Innovation with Sabrina Johnson, CEO of Dari Bioscience

Dr. Sameena Rahman (: 00:30

Welcome to another episode. Today we're gonna talk about something that in medicine is historically avoided and frankly underfunded. And so we're gonna talk about women's sexual health, which I talk about every single episode almost. You know, for decades men had Viagra, they had endless investments, they had direct-to-consumer ads during football games, and women were told to relax and have a glass of wine. today we have someone who is working hard with the rest of us to try to change it in a big way.

Sabrina Johnson, she's the founder and CEO of Dari Pharmaceuticals or Bioscience, a company that's focused entirely on women's healthcare and innovation, which is amazing. From contraception to menopause to sexual arousal, we're gonna talk about all of it. We're gonna talk about the stigmas around it, the business realities, and why investing in women's health is so long overdue. Thank you, Sabrina, for being here.

Sabrina (: 01:23

Yes, my gosh, thank you so much. I'm so excited about the conversation.

Dr. Sameena Rahman (: 01:27

Yeah, I can't wait. And Sabrina and I met, full disclosure, I've done some medical advising for Dari. And so I, because I'm a big believer in what she does and her products. And so, which we're going to talk about one of them because we're waiting, we're waiting. So we're going to do that. But I like to always start with, you know, I'm a guy and a girl and I like to see like, you everyone has a backstory in comics. What is your backstory and what brought you into this part of women's health?

Sabrina (: 01:42

So, that's what happened.

Sabrina (: 01:57

Absolutely. So as you alluded to, Dari Bioscience is really a purpose driven biotech. Our sole focus is closing gaps in care for women, right? Developing therapeutics to address those needs that have not been addressed before. And my backstory is I've spent my entire professional career developing medicines for people.

And I've had all the roles. I was a bench scientist. I've been a marketer. I've been a chief financial officer. I've done regulatory. I've done all of it. And before forming Dari, I've worked in pretty much every therapeutic area almost imaginable across healthcare. So I've had the privilege of getting to really make a difference in a lot of different disease areas.

But several years ago, it occurred to me after watching all of this, I kept seeing gaps in care in women's health. And when I had an opportunity to make a change, I thought I really want to make a difference there. I would love to really focus in and work with an organization that is going to be focused on women's health. And as I looked around, I couldn't find anyone doing it. When I got to the point for me, right, where I really wanted to make that happen,

no one was doing the work and after, you know, spending several months, almost years saying to my, to my husband, why is no one doing this? Why is no one solving these problems for women? You kind of wake up one morning and realize, well, I'm someone I could, you know, I can make a difference. And I, and I have that background. Right. So, so I did. So I started the company 10, 10 years ago, actually 11 years ago now.

Dr. Sameena Rahman (: 03:31

Yeah. right.

Sabrina (: 03:43

With that sole focus, right, let's figure out where there are some of the biggest gaps in care and how can we make a difference very quickly, right, to get real world solutions in the hands of women as quickly as we possibly can.

Dr. Sameena Rahman (: 03:58

Thank

Sabrina (: 03:59

So that's the backstory and here I am. So, you know, fast forward, here we are today with Dare.

Dr. Sameena Rahman (: 04:07

Nice. I love it. I mean, this is amazing. Honestly, you know, it's such a challenge. Sometimes you feel like you're beating your head against a wall. Like, why cannot we not move this needle forward?

Sabrina (: 04:20

Yes.

Dr. Sameena Rahman (: 04:22

I think a lot of my listeners have watched or heard me talk about the pink pill. And that is just one sort of example of the journey to get sexual medicine, medications for women with Cyndi Eckert. I wanna ask you from your perspective too, why do you think pharma in general has such a hiccup when it comes to investing in female sexual products or products that, I mean, think some of these non hormonal

products are getting a lot of investments and you know a lot of things that I think are more like on the unique side but what like what's the deal like I feel like this is why we have such a predatory market but what do you see is like the biggest hindrances around is it just the taboo of sex or is it what is it?

Sabrina (: 05:11

It's a lot of factors. And I think definitely the taboo is one aspect of it. But I have to tell you, I mean, we look at that and that's part of what we see is the opportunity. Let's change the conversation. And we look back in time, right? We think men have had Viagra now for almost 30 years. And before Viagra, no one talked about erectile dysfunction, right? That was taboo. There was stigma. There was embarrassment. I can look at that. Right.

Dr. Sameena Rahman (: 05:18

Thank

Dr. Sameena Rahman (: 05:36

Yeah, they call it impotence. Yeah.

Sabrina (: 05:41

Right, right, exactly. And I can look at a lot of other healthcare areas and see similar groundbreaking moments where, you know, suddenly having a solution changed the stigma around a condition. Mental health is a great example, you know, of that. But all of those big innovations, you know, took companies, the pharmaceutical industry, in some ways being brave.

and patients being brave, right, and speaking out. And sometimes it's hard to be brave, right? So if you are a pharmaceutical company, sometimes it's easier to work in the areas where everyone else is doing the work.

Dr. Sameena Rahman (: 06:09

Yeah. Yeah. Yeah.

Dr. Sameena Rahman (: 06:23

diabetes. I mean, I live down the street from where ASCO is every year and it blows my mind. the number of like the first of all, thousands of oncologists are walking through my neighborhood and like literally like the amount of pharma input is astronomical. Like it's amazing. And I want to be treated and cured, like, know, wow.

Sabrina (: 06:43

That's a great, like, that's a perfect idea.

Sabrina (: 06:49

Well, it's a perfect example. I will say, so Dara Bioscience, are, to our knowledge, we are the only publicly traded, you know, pharmaceutical company working solely and broadly in therapeutics for women's health. And it is because, you know, it is, it's a lift to do that work. And if people haven't watched the Pink Pill documentary, it is a great example of what it takes.

Dr. Sameena Rahman (: 07:04

Crazy.

Sabrina (: 07:16

to innovate in an area where there hasn't been prior innovation. And the example in that is sexual health. But I will tell you as someone who has historically innovated in other therapeutic areas where we didn't have solutions in medicine, it's always hard being first. Right? It's always hard being first. You're breaking the ground, you know, for everyone. But that's the work that has to be done. And when you do that, you know, there's great, there's great.

Dr. Sameena Rahman (: 07:34

Yes, sir. Yeah. Yeah.

Sabrina (: 07:44

reward in serving people that haven't had a solution.

Dr. Sameena Rahman (: 07:52

No, totally. mean, obviously, you know, I'm sure one of the, you know, I always think obviously it's like the amount of patriarchal sort of standards that exists within the medical community, like our paternalism toward women. I mean, that was a stark reality. I mean, that picture where they were like, well, what if she's so sleepy she can't take her kids to school the next day? You know, like, that was like.

Sabrina (: 08:07

us.

Sabrina (: 08:14

I know, I know, I know. And it does exist, I'm not gonna lie, right? Like there is, that's part of the challenges in our society, right? That that exists.

Dr. Sameena Rahman (: 08:28

And these are other women, some of the times it's other women asking the question.

Sabrina (: 08:32

Absolutely. No, absolutely. It's because these are conversations we don't talk about sex. We don't talk about menopause. We don't talk about change. We don't talk about periods. We didn't write things are changing. We're starting to have those conversations. But until you you have the conversations and use the words I give the example I was invited to at one point to be on this podcast that airs on certain NPR stations and affiliates. And when I describes our the things we work on, we do a lot of vaginal

drug delivery, lot of products that affect the vagina or affect, right? And after we recorded, they told me they couldn't use it. Right, they told me they could not use it because I said vagina too often. And, know, it's, it's the anatomy. I'm not gonna, you know, who, whoever.

Dr. Sameena Rahman (: 09:06

Yeah. Probably couldn't say a vagina. Yeah.

Dr. Sameena Rahman (: 09:17

my god, that's so annoying actually. Let's not say eyes are green. Should we not say eyes, brain, teeth? Like what? I mean, it's crazy.

Sabrina (: 09:28

Wait, wait, right. But that's, you know, that's, that's, again, it's stigma, right? There's stigma, there's words we don't use, there's things we don't talk about. But, you know, that's the reason though, women, we can make a difference, like speaking out, right? Asking for solutions, asking for information.

Dr. Sameena Rahman (: 09:44

Yeah. Do you think?

No, for sure. And do you think that like

Yes, 100%. Do you think that, I mean, obviously we talk about the ideas of like patriarchy and sexism and all the things that kind of like, you know, sort of coat our society. I mean, I always, when people talk about OBGYN, I'm always like, you know, this is a field that was founded on racism and sexism, right? Like, is this our foundation that we've had to chip away at, you know, since its beginning, but do you think there's also this element of like,

You know, we're gonna talk about some female pleasure stuff in a minute, but like, do you think there's an element of like people, that these people are fearing women getting pleasure? Like, you know, like what happens when a

Sabrina (: 10:39

Run away.

Dr. Sameena Rahman (: 11:02

I don't know, it's been, I don't know if it's my internet or what, but I think it's been a little poppy.

Sabrina (: 11:05

Yeah, you just went away all of a sudden. You were gone.

Dr. Sameena Rahman (: 11:08

no, it just like cut off. I might, I'm just gonna get my phone out in case I have to use it. I usually record in this high rise area and so sometimes rarely I'll get choppiness.

Sabrina (: 11:24

Yes, you were gone. You were gone for a while. And you were...

Dr. Sameena Rahman (: 11:24

But don't worry, Carrie will put it, she'll put it all together. it'll be.

Sabrina (: 11:29

Yes, that's what I figured. And you were cutting out a little bit at the end. So I missed, like, all you were saying, brilliant things, because super animated, but I was like, wait, I can't hear you.

Dr. Sameena Rahman (: 11:34

I will just, we'll ask. I can't see what she said. Okay. All right, Carrie, start from here, I guess. So, you know, we think about, we're talking about a lot of the things around, you know, the fact that obviously sexism exists in our society, those patriarchal norms. And, you know, I always talk when I teach about sort of health inequities in OB-GYN, I always talk about how

really our foundation in OBGYN is on the backs of racism and sexism because even our most beloved gynecologists used to treat unanesthetized slaves to try to figure out the best procedure for white women. But I want to be cognizant of the fact that this exists and this is probably a problem in trying to get drugs that are for female arousal and pleasure, which we'll talk about. But I also wonder how much is it that

A, women don't seek their own pleasure. They don't think that they deserve pleasure. And B, men fear that pleasure. Like, you know, where do you think that is this junction of...

Sabrina (: 12:40

I definitely think that I'll please Ben. So going to the medical part first, right? And how we think about women. I think part of the challenge is definitely that often when we're thinking about women, we're also thinking of them as a medical, not a medical society in terms of practitioners, but a regulatory body looking at medicines for women, right? We're often thinking about just her, but the fact that she could conceive, right?

Dr. Sameena Rahman (: 12:45

Right?

Dr. Sameena Rahman (: 13:03

Yeah.

Sabrina (: 13:09

we have a baby, right? What's going to happen to the baby? And so kind of going back to even some of the earlier discussion about what makes it so hard if you're trying to develop pharmaceuticals for women, part of it is you have to think about, I want to make sure that I'm showing that whatever I'm developing is safe for her, but also what might happen to a fetus. And it's an extra burden, right? But if you're serious about helping women, that's something you have to look at.

Dr. Sameena Rahman (: 13:14

Yeah.

Dr. Sameena Rahman (: 13:19

to hold.

Dr. Sameena Rahman (: 13:36

and

Sabrina (: 13:38

But to your question though, around one, what even women feel like women as themselves, what do they feel like they deserve? I will tell you in our clinical studies, and we've talked to so many women with arousal disorder and other sexual dysfunctions, there is absolutely a level of guilt, a level of, and we see that, we see that in our studies.

women come in very distressed about, you know, why is this happening? Why am I not feeling the way I used to feel? And, and like I said, guilt and confidence around it as well. So I do think, and that's cultural, right? I think there's a cultural component to that, right? On the one hand, not feeling like you deserve pleasure for yourself, and also feeling this responsibility of what role you might have in a relationship with your partner.

Dr. Sameena Rahman (: 14:26

Yeah.

Sabrina (: 14:38

in terms of what you're supposed to be delivering or what is expected from you in that relationship. So we definitely see that when we've engaged with women and they talk about what they're experiencing and how they feel about having less physical sensation. Because that's what we focus on as a company is how can we improve, right? How can we enhance?

what happens naturally and give a little help. Again, kind of like you do with men with erectile dysfunction, you're just giving them help with something that they want to have happen. But we definitely see women, you know, they talk about it, the frustration that really for them translates into guilt, know, confidence, even maybe stress then about a sexual activity because they're not sure. And then there's definitely a piece of it.

Dr. Sameena Rahman (: 15:02

Yeah.

Dr. Sameena Rahman (: 15:09

No.

Sabrina (: 15:30

I will say, so, you we talk to investors all the time because we, we, that's how we do the work that we're doing, right? People that research. thank you. but when we, lot of them were talking to male investors, they will ask about, know, yeah, they'll say, wait, so why does that matter? Like, you know, we're talking about how important it is for women to have an approach. You know, I've often gotten like, why does that matter?

Dr. Sameena Rahman (: 15:34

Yeah. Yes,

Dr. Sameena Rahman (: 15:45

It's on the roof.

Dr. Sameena Rahman (: 15:56

Why is it... So crazy, right?

Sabrina (: 15:59

And, you know, I always say I feel sorry for your partner. If you're wondering.

Dr. Sameena Rahman (: 16:05

No kidding. I'm sorry.

Sabrina (: 16:11

I think, you know, but it goes back to your question though, really fundamentally, right? Is that as a society, haven't, we haven't elevated that for women. We haven't elevated that right.

Dr. Sameena Rahman (: 16:27

Great. Well, don't teach teenagers or girls and women about what are their pleasure, the number one pleasure organ they have that they don't know anything about. We didn't study that we never examined, that we never thought we should deal with. I so I think it's from top down and bottom up too. It's like both issues. We don't educate women that they deserve pleasure and this is how they can attain it. But we also don't educate the clinicians and the doctors and all the people.

Sabrina (: 16:46

exactly.

Dr. Sameena Rahman (: 16:56

how can we assess for it and is this a conversation we should be even having? And so, which brings us to like, let's talk about one of the drugs that we're all waiting desperately to get. I talk about it literally every day. mean, and I don't get a kick back for it. if you ask why I talk about it every day in my office, because, know, inevitably everyone in my office, midlife or not has.

Sabrina (: 17:14

Thank

Dr. Sameena Rahman (: 17:21

you know, desire disorders. And then most of them, they're in long-term relationships, we talk about responsive desire. And then we talk about arousal and then this is how it comes up. So tell us about this, like, where did you come up with this? How did it start and what is it and what does it do? Tell us all about it. The name is interesting though. have to say, get like mixed emotions about the mains. Sometimes we're like, that's kind of a strange name. I'm like, no, you have to dare to play with yourself.

Sabrina (: 17:36

Absolutely. So, so fundamentally as a

What?

Sabrina (: 17:50

Yeah, well, can come in parts. So going back to the back story. So the company name is Dare Bioscience, spelled like dare. And I'm Italian. And I founded the company. So I got to name the company. That's the perk of founding a company. You get to name it. And dare, we don't use the accent in Italian. But dare in Italian means to give. And obviously, dare in English means to be bold. And yeah, the foundation of the company is we are daring.

Dr. Sameena Rahman (: 17:54

Yeah. Yeah. Yeah.

Dr. Sameena Rahman (: 18:05

Yeah.

Dr. Sameena Rahman (: 18:16

I love that.

Sabrina (: 18:18

right, to give women the healthcare solutions that they deserve. And now that we're starting to commercialize products, you know, we're trying to have DARE somehow in the name. So we have DARE to Play, Sexual Health, DARE to Restore is for vaginal health, right? We get the idea. A lot of DARE to Reclaim, for menopause, right? So they all have DARE in it. And it's really about, you know, women were over being overlooked, right? So.

Dr. Sameena Rahman (: 18:23

Yeah.

Dr. Sameena Rahman (: 18:35

yeah yeah

Sabrina (: 18:46

It's time we're daring to like bring stuff back for us. So just the background on the name.

Dr. Sameena Rahman (: 18:50

I didn't know that see say I learned something today. That's really

Sabrina (: 18:53

Yeah, yes, that's where it came from. as a company, as I mentioned, what we try to do is figure out where are there gaps, right, therapeutic gaps in care for women. But we really want to focus on where we can get solutions to women very quickly, right? So what we want to try to always do is prioritize.

solutions for women where we know the science and we can be that powerful bridge to move that science forward and get the product in the hands of women. So, you know, when we started the company, you know, 11 years ago, we went around talking to healthcare providers and women around where's the gap, right? Where do you not have what you want? Where would you like a solution? And we would

design, I call it our blue sky process, would design, like, pretend there's no limitations, what would be the perfect thing, right, to solve that problem. And when we were talking to women about sex, because we felt, you know, again, we're mostly women developing for women. So we also came in with preconceived notions of where we thought we should be working from our own life experiences and our girlfriends. And so what, right?

Dr. Sameena Rahman (: 19:52

Yeah.

Dr. Sameena Rahman (: 20:00

Yeah.

Yeah.

Dr. Sameena Rahman (: 20:09

True.

Sabrina (: 20:12

So while we talk to people about sex and sexual fun, and what they wanted out of that, two things came out of it. One is we definitely found there was a challenge with the language. How do we talk about it? Because, you kind of, touched on this when you talked about desire versus and responsive arousal and, you know, so part of it was trying to understand, you know, what are you actually looking to solve?

Dr. Sameena Rahman (: 20:15

Right?

Dr. Sameena Rahman (: 20:28

Okay, yeah.

Sabrina (: 20:41

And when we kind of got to the bottom of what they're looking to solve, what we really kind of heard consistency that they were looking to solve when you really dug in to understand what they were saying is they wanted more physical sensations, right? They were feeling like maybe over time, they weren't feeling the same level of sensations that maybe they felt years ago.

Dr. Sameena Rahman (: 20:57

Yeah. Yeah.

Sabrina (: 21:10

And maybe they weren't also getting the same amount of lubrication that they used to get. And also in the conversations of recognition that when you really dug in, that many times they understood that responsive around desire concept, that they understood that what needed to kind of happen first is to have the kind of pleasure conversations, right? Things getting kind of.

Dr. Sameena Rahman (: 21:31

No. Yeah.

Sabrina (: 21:34

warmed up and going and then they would feel more desirous in the moment and more excited about what was going to happen. So when we take a step back then and think about, what makes that biology happen? It's, you know, the same is what happens in when. In that physical arousal response is blood flow, right? You're getting blood flow to the genital tissue. That's what's causing

Dr. Sameena Rahman (: 21:55

Yes.

Sabrina (: 22:01

the pleasurable sensations, the warmth, the tingling that happens early on, the natural lubrication that comes from blood flow. So then it became kind of like, wow, well, that medicine exists. Viagra has been on the market for very long time for men. And that's just one example. But there several of these kind of drugs that do that. That's what they do mechanistically. They're designed to just increase blood flow. And so then we just kind of went back to that target product profile, because what we heard from women is,

They wanted something to do that, but they did not want to have to take something early. They did not want to have to take something every day. They wanted it to happen in the moment. They liked the idea of something that was kind of like a lubricant and form factor in that they kind of understood the concept of something you would apply before sexual activity. But then they also, that meant they wanted it to work really quickly.

Dr. Sameena Rahman (: 22:36

every day.

Sabrina (: 22:59

It had to be fast acting. They didn't want to have to rub something on and wait for 30 minutes for it to take effect. And so we just took that feedback. And then we went and looked for how to do that. And it turns out it was actually a lot harder than I would have thought. Because it turned out those drugs that are really fantastic given orally for men.

Dr. Sameena Rahman (: 23:06

Yes. Yeah.

Sabrina (: 23:28

for reptile dysfunction, are, and sedentifil in particular, is actually really hard to formulate into a topical formulation that actually gets through the skin and the tissue. Our body, our skin, and even our mucosal membranes are designed to be protective. They're designed to keep stuff out. Yeah. So we had to find the perpetuity actually.

Dr. Sameena Rahman (: 23:41

Yeah.

Dr. Sameena Rahman (: 23:50

kind of change. Yep, exactly. Yeah, so true. And you see it. mean, get this secondary pieces, you know, all the all the ones that are popping up left and right. But but continue your thought on that.

Sabrina (: 24:03

Yeah, no, I did. I'll finish on that. It was like the secret sauce here, quite frankly. The first step was finding actually a delivery technology. And ours is Dermaflex. we got it from another company that had developed specifically this delivery technology for topical products, specifically ones that are, it's called a highly charged molecule and that are difficult to get into this. They did it with like

nonsteroidal anti-inflammatory drugs that are also traditionally kind hard to get in, which is why have been topical pain. Drugs don't work very well. And they had also, they were able to do this with sildenafil. And so then once we had the formula, was really, for us, the first step was actually answering the question of like, does it work quickly? That was such a big part of the product profile that we heard consistently. So after

Dr. Sameena Rahman (: 24:40

Yeah.

Sabrina (: 25:00

doing a whole bunch of studies to show, you you do all the studies in animals to show it's okay there and all different kinds and you do.

Dr. Sameena Rahman (: 25:06

Yeah, walk the listeners through in case they don't know the number of phases needed. So, what was one?

Sabrina (: 25:10

my goodness. So to give you some perspective, yeah, so to give you a perspective, actually, I'll walk through all the stuff, to give you a perspective. And particularly if we wanted to make sure that we looked at all the different ways and all the different orifices that the product might come in contact with, right? It's designed for vaginal and topical genital delivery. But so we did, and I'm a vegan, so I don't like to do animal studies, but we have to, it's the law.

Dr. Sameena Rahman (: 25:28

Yeah.

Dr. Sameena Rahman (: 25:38

Yeah.

Sabrina (: 25:39

So we did studies to look at oral toxicology, anal toxicology, vaginal toxicology in animals to show really long studies to show super safe in all those places. Then we had to do studies in men and women called phase one where they're healthy. And in women, looked at both pre and post menopausal.

because there can be changes in the vaginal tissue, so the profile can be a little bit different from a side effect profile, so we needed to look at that. Then, so you do all those studies. We also did what's called reproductive toxicology. I talked earlier about if you're going to study something in women that they're going to use a reproductive age, we want to be super sure that we understand what it does and most importantly, what it would not do.

negative, right, to if she gets pregnant. Did all that work? And then you start to get into studies to look at, you know, the population of interest, right, people that have decreased arousal sensations, right? And you don't just go and do that study either. First, we show that the product gets into the tissue really quickly. So that study was a

Dr. Sameena Rahman (: 26:48

Thank

Sabrina (: 26:58

crazy study where women had to be in like stirrups and with a heat sensing camera focused, you know, right on their vagina and clitoris. And that's how you can see that it gets in quickly. Yes, we did that with Irwin Goldstein. then,

Dr. Sameena Rahman (: 27:05

Yeah.

Dr. Sameena Rahman (: 27:11

Did that study with Erwin, the thermographer?

Sabrina (: 27:22

In our case, ultimately, this is being made available right now as what's called a compounded product, but we want to ultimately make it available as an FDA approved product. And so the next step then is working with the Food and Drug Administration to even just discuss what are the questions you ask women? How do women talk about arousal? It's not practical to do all the studies and have people have sexual activity in a laboratory and then look at heat.

Dr. Sameena Rahman (: 27:40

Yeah.

Sabrina (: 27:51

and blood flow, have to figure out what are the questions to ask. And that wasn't trivial. That was research we had to do just on its own with women. What are the questions? And then you go in and we did a study that is what's called placebo controlled, which means half of the people in the study get the cream, just the base cream, the Dermaflex technology with nothing in it. And then the other half get the actual DertaPlace and NFL cream product.

Dr. Sameena Rahman (: 28:15

you.

Dr. Sameena Rahman (: 28:20

Mm-hmm.

Sabrina (: 28:20

And then we look at all those questions specifically around arousal sensations. But we also looked at downstream effects, like the desire that we talked about, or even orgasm. We also looked at those questions that we learned from women that they also had in terms of interpersonal difficulties, the guilt, the confidence, the stress about sexual activity. Because you want to see that you're, how does the product change that?

Dr. Sameena Rahman (: 28:40

Yeah.

Sabrina (: 28:49

And it wasn't enough to just ask women how they were doing. We also wanted to look at what happened to the partner. Because the partner's going to get exposed to the product. So we also wanted to understand what happens with that partner exposure. Number one, we keep it.

Dr. Sameena Rahman (: 29:04

What does it taste like? That's one question I get asked almost. What does it taste like in case, you know? I lost you for a second. you froze for a second.

Sabrina (: 29:10

I was just going to say the number one question we get asked is what does it taste like? So I tell you, it's a little salty. sorry. My back.

Sabrina (: 29:24

I can see you. Okay.

Dr. Sameena Rahman (: 29:25

Okay, now, okay, I asked you what it took. It might have uploaded, but I don't know, just in case.

Sabrina (: 29:31

Okay, yeah, know that that the number one question we get also is what does it taste like? And unfortunately, participants in the trial had a lot of oral sex. Yeah, participants in the study had a lot of oral sex, so we had a lot of opportunity to get the feedback on what it tastes like. And it's a little salty, there are salt in the formulation. And so some people that you know, the thing they would report is a saltiness, a slight saltiness.

Dr. Sameena Rahman (: 29:42

Yes.

Dr. Sameena Rahman (: 29:50

Yeah.

Dr. Sameena Rahman (: 30:00

Right.

Sabrina (: 30:02

So yeah, but totally that listeners a sense there's a lot, there's a lot that goes into it and then you're not done there, right? We also want to make sure if this is being made available as a compounded product. And what that means is that the FDA has not yet reviewed the safety and effectiveness. We've submitted things to the FDA, right? But they haven't thoroughly reviewed the safety and effectiveness. Those data are available, but what's important

Dr. Sameena Rahman (: 30:29

And if you know, you watch the pink pill, know how long it takes the FDA to approve things. is it six years or something? can't remember.

Sabrina (: 30:36

Yes, I mean, we've said people know this who follow our company. We've been in discussions with them for two years now since we completed what's called the Phase 2 trial to align on design of the next phase that's required for registration. So it's a long process and that's ongoing for us, which is why we are really thrilled that there is a way to respond to health care providers and women who are coming to us and saying we want the product.

Dr. Sameena Rahman (: 30:47

you

Sabrina (: 31:02

Now we don't want to wait. There's nothing else available. Can you find a way to make this available? And we're thrilled that we were able to partner with an organization to do that. there's pharmacies can make you products, but for something like this, where it's really important that it's made, it's a very specific formula of how you make it and not just the ingredients, but how you mix the ingredients, how they're blended together to get the sidenafil into the tissue.

you know, making this at a pharmacy just was not an option for this formulation and wouldn't have the control.

Dr. Sameena Rahman (: 31:36

which is what typically happens in a compounding situation, right? When we don't have an FDA-approved product, some of us will move toward compounding, and then this is what happens. You have to find a trusted compounder that has some regulation that if they say they're gonna put estradiol in it, that it's not a gummy or something.

Sabrina (: 31:56

Exactly. Exactly. And for us, with this particular formulation, because of how difficult sidenethyl is actually to get into a cream in this way, even if we'd wanted and found a great trusted pharmacy compounder, they actually would not be able to make the product. They would not be able to make this product. And so what we were thrilled is that under the FDA rules, they also allow for

facilities that can make a product at a larger scale, which is what this formulation requires with the specialized equipment and how it all has to be mixed and made in order to get this identity to work the way you want it to at the single time. yes, everything is exactly the same. And so we were able to work with this partner that can, they have to report to the FDA, they have to follow all the FDAs.

Dr. Sameena Rahman (: 32:32

And the same standard in each packet, basically too, right? Like you want to make sure you're

Dr. Sameena Rahman (: 32:47

Yeah.

Sabrina (: 32:47

standards for pharmaceutical products, which is what you're alluding to, that they have to be, the tube you get today has to be exactly the same as the tube you might get two years from now. That's the level of scrutiny and quality. And so we're really happy that we're able to do that. And it is coming soon. That process is, to do it at that level, it takes a lot of registrations that the facility has.

Dr. Sameena Rahman (: 32:56

Right.

Dr. Sameena Rahman (: 33:05

No.

Dr. Sameena Rahman (: 33:12

Sure.

Sabrina (: 33:13

go through, not just with the FTA, but with every single individual state. And not every state is the same in terms of what they're acquiring.

Dr. Sameena Rahman (: 33:18

to get right. Yeah. And I think that's why you have to batch, you have to batch the functions right too. So, which is why we started collecting in January, I think, or something like that, in most states, in some states.

Sabrina (: 33:26

Yeah.

Yes, yeah, February 1. Yep, exactly. Exactly. So we're getting there. We're getting, you know, things down. So getting closer to having it available on.

Dr. Sameena Rahman (: 33:37

Oh, it froze again. Do see me? Yes. OK. Yeah, awesome. I mean, that's so interesting, I think, because people don't realize or recognize how much work and effort it takes to get a product out, right? Because I always tell them, like, because obviously, in Sexmed, we have to compound some things. We don't have everything to do with

Sabrina (: 33:57

Peace.

Dr. Sameena Rahman (: 33:58

And so, you know, I would say, well, the difference is like trying to find a trusted compounder, because it's like if you go to, you know, a dispensary and get a gummy that you want to help with sleep, but it tastes like candy and one day and the next day it knocks you out for three days. Like, that's the thing. Like, you don't know because there's no, you know, formulation. But and tell me how you would explain because I was talking.

Sabrina (: 34:17

Exactly.

Dr. Sameena Rahman (: 34:25

to a few other doctors who are pretty much never do compounding at all. They're very opposed to it. But...

you know, how do you talk to people who, you know, think to make this, to think of this in a different way? Like, what messaging do you give? Because I think that's what, you know, she was alluding to is that she, she's someone that speaks out against compounding, but yet is a real supporter of Dari. And so she kind of like was saying that people came for her because, you know, what happened to your anti-compounding stance? And so like, what kind of messaging would you then?

say it to the communities at large to make them understand why this is a different product compared to.

Sabrina (: 35:09

Yeah, it's great question. And I will say as someone who has spent my, you know, over 35 years now, shocking for me, in the industry of developing medicines and pharmaceutical products, and having spent an entire right career, having to work towards the kind of quality standards and consistency that is expected when a product

Dr. Sameena Rahman (: 35:26

Yeah.

Sabrina (: 35:37

is going to ultimately attain an FDA approval and be manufactured under what's called good manufacturing practices for pharmaceuticals and those quality standards. I too have recognized that pharmacy compounding serves a need, right? There may be that like individual patient that needs something that is just not available another way. And you simply, you know,

Dr. Sameena Rahman (: 35:55

Yes.

Dr. Sameena Rahman (: 36:02

you know, or they react to some product in a bigger batch of things, you know, that kind of thing.

Sabrina (: 36:07

Exactly. Like they need something. And so I understand there's a place for that. But the challenge with that is all the things that you talked about, that there's not the same consistency. So anytime that there's an FDA approved product in that same form factor, right? Like if you're looking for an estradiol cream, and there is an FDA approved estradiol cream, that FDA approved version is always 100 % of the time going to be at a higher standard of quality.

Dr. Sameena Rahman (: 36:15

I'll talk to you later.

Sabrina (: 36:37

and consistency, it's legally required under good manufacturing practices than a compounded product, which are just not held to those standards. And it's not that they're bad at a pharmacy. And I'm talking about pharmacy compound. So for us, what we needed to figure out is we need to feel comfortable that we're operating over here at the same level of good manufacturing pharmaceutical standards as if the product were FDA approved.

Dr. Sameena Rahman (: 36:48

Yeah. Yeah. Right.

Sabrina (: 37:06

even though it's not. And that is a, it's a higher bar. It's a higher bar of testing. It's a higher bar of quality control. It's a higher bar of sourcing back every single ingredient, right? Every single line, every single batch. And that's just not achievable at pharmacy compounding, not because they don't want to, but because those are not the standards that they're held to. And also the sizes of batches that they're manufacturing, you could never do that.

Dr. Sameena Rahman (: 37:18

Yeah

Dr. Sameena Rahman (: 37:25

I I want to.

Sabrina (: 37:35

So that, think, is why some people who have been anti, in general, compounding have embraced and have thanked us for making this available because it is at a different quality standard. And also because we are doing the work. We have done work. The other thing is a traditional compounded product has zero, zero, zero, zero, zero, zero actual data on its formulation.

Dr. Sameena Rahman (: 38:03

Yeah. Yeah, they don't have, right.

Sabrina (: 38:05

Right? All you know is the goals you might have by saying, well, Sedentifil does something cool in men. I'd love to mix it into a cream. I sure hope it's going to have that effect in women. And the different here.

Dr. Sameena Rahman (: 38:15

Yeah.

Yeah, we'll hope that it makes someone scream. I don't know. Yeah, we hope.

Sabrina (: 38:24

Exactly, like that. And the difference here is that we've done work to demonstrate for this specific formulation, this specific formula that we're making, what it does. So you know what to expect. Whether that's in, we talked about the reproductive toxicology studies that we did to make sure that it's new and no harm from a reproductive perspective.

Dr. Sameena Rahman (: 38:45

Yeah. Yes.

Yeah. And for my partner's reptile dysfunction, she looked at that. It doesn't, right? They still need to take it orally.

Sabrina (: 38:51

to the studies we've done. Yeah. Cool.

Sabrina (: 39:04

Well, I will say we are going to come out with some data. There is some data looking at this formulation in men. It gets through the tissue. It does, you know, the sedentary kiln. Yeah, so we'll have some published findings out on that too, ultimately. Yeah, exactly.

Dr. Sameena Rahman (: 39:11

Okay.

helps a lot.

Dr. Sameena Rahman (: 39:24

So yeah, could be dare to play for two maybe. That's really cool. Okay. And so tell us, I know there's other things in the works too, because you're just not dare to play. What other things are in the works? Or I know for menopausal women, for younger women, what do you got?

Sabrina (: 39:42

Yeah. Yeah. So again, everything we do, it kind of comes back to, you know, show it, not just assume what something is going to do, but generate the data to show it. And there are a couple other there are two other categories where I'm really proud of some things that are coming out where that that we have a lot of gaps and the standard has not been show what it does. What is in the vaginal kind of the vaginal health space? We're hearing a lot more about

vaginal microbiome, microbiome in general, right? We now talk about our gut microbiome and we're drinking probiotic sodas and, you know, doing all this stuff for our gut microbiome. And we're starting to learn about our vaginal microbiome and how important it is to keep that kind of ecosystem working well, because when it is disruptive, it actually can lead to serious health outcomes. It increases your risk for more serious, like serious infections. And also, you know, could

Dr. Sameena Rahman (: 40:12

Yeah.

Sabrina (: 40:38

lead to even preterm birth and fertility. There's a lot of reasons to try to keep it healthy. And so there's been a lot of buzz about probiotics and probiotics for the vaginal microbiome, most of which are oral, which makes no sense. That's not down there. It's not happening. And so we are launching coming soon. It's called FloraSync LF5. It's in what we call our Dare to Restore. So they all have Dare, Dare to Restore family products.

Dr. Sameena Rahman (: 40:42

Yes.

Dr. Sameena Rahman (: 40:46

Yeah. Yeah. I know. know. know. know. Yeah.

Sabrina (: 41:08

a probiotic that was actually developed in Italy by a company that isolated from women basically that have self-reported that they've never had a yeast infection, right, which is the pain that women get a lot. They isolated a strain of bacteria from them and then studied it in women. So it's been studied and published in women to really show that the probiotic

Dr. Sameena Rahman (: 41:12

Thanks for the...

Sabrina (: 41:37

is doing what it is supposed to be doing in terms of creating that healthy, balanced microbiome environment. So that is coming soon. And we're really excited to bring that here to the US. It's from Italy. Excited that women, yeah, to bring it here. then menopause is one of those other, menopause hormone therapy is a category that we have kind of from day one at DARE has just perplexed us in the fact that we know

Dr. Sameena Rahman (: 41:49

Nice.

Dr. Sameena Rahman (: 42:03

and they can see it in thousand years.

Sabrina (: 42:06

For kind of estradiol and progesterone, we know the levels that one needs to be delivering to kind of return someone to premenopausal. We have read with great interest all the guidance from the menopause society around recommending that not more women be preferred if possible. And also for women with a uterus, having both progesterone and estradiol together, your progesterone's there for safety.

Dr. Sameena Rahman (: 42:10

Yes.

Sabrina (: 42:34

and estradiol is what's going to do the work to replace the hormones. And yet there's nothing out there that has been clinically studied to do that. this is a sector where there's a lot of compounding with no data, right? It's scary to me compounding like fillings, better than inserting it and you don't know what you're getting and what are the levels, what are you returning to? So we've developed a vaginal ring, it's just a once a month.

product that's inserted vaginally. has estradiol and progesterone together. It's already been studied in a study.

Dr. Sameena Rahman (: 43:10

So this is like the micronized pedestrian. It's not synthetic, right? Yeah. Are you going to come up with No.

Sabrina (: 43:14

Yeah, is. it's bioidentical. Yeah, micronized and with estradiol. And it's in just this once a month vaginal ring. And we've studied it.

Dr. Sameena Rahman (: 43:23

How big is the ring? They say the progesterone molecule is a little bit bigger, right? So has to be a bigger ring.

Sabrina (: 43:29

Yeah, it's, I mean, it's, I don't have one right here. Yeah, and we've already studied it in women. We've run two different trials, you know, in women, post-menopausal women to understand, you know, what do they see, you know, can they insert it? Is it comfortable, right? All those kinds of questions. But also importantly, we wanted to show that when we look at blood levels, because we're really looking, even though it's vaginal, it's really to deliver the hormones for systemic effect.

Dr. Sameena Rahman (: 43:32

Yeah, it's the size of us.

Dr. Sameena Rahman (: 43:37

Not

Dr. Sameena Rahman (: 43:56

And yeah.

Sabrina (: 43:57

Right. So we know estradiol can be so important in not just your vaginal health, but your bone health, your cardiovascular health, your brain health. so wanting to show that we get to the levels that women have, we look at like we're trying to match to the follicular stage. Right. There's different levels throughout like the menopausal cycle. So we're looking to match to follicular stage levels for both the estradiol and the progesterone.

Dr. Sameena Rahman (: 44:05

Yes.

Dr. Sameena Rahman (: 44:12

Yeah.

Sabrina (: 44:21

and then that's been published. And so we're looking to make that available. We're targeting next year. We're working hard to make it that next year.

Dr. Sameena Rahman (: 44:21

Something. No.

Dr. Sameena Rahman (: 44:27

Wow, that's amazing. know, because the truth is, and I'm curious, I haven't read any of the studies yet, but you said one was published already,

Sabrina (: 44:37

They're both published. Yeah, all the studies. Yeah, both sets of studies.

Dr. Sameena Rahman (: 44:39

Okay, so because I was curious to see, know, there's a lot of times people don't tolerate oral micro-inspir a while, they have side effects. And so sometimes we'll tell them to put it vaginally, they have less side effects, but think still you have uterine protection. So I'm wondering about that. Like, did you look at whether or not the people that were doing it vaginally, you got any of the benefits that we normally see, right? Like sleep or the mood or the whatever?

or if

Sabrina (: 45:08

We did, yeah, we looked at, that's a great question. We looked at, yeah, so we looked at that, it's called the MQAL, like a menopause quality of life that has a lot of questions around, yeah, so we saw, you we saw the improvements that we had hoped and expected to see, right, with the delivery, so yeah. I will, I will, yeah, I'll send you the publications. We did two studies, so one, and actually just a funny story about it, so we do a lot of these,

Dr. Sameena Rahman (: 45:15

Yeah. Yeah.

Dr. Sameena Rahman (: 45:23

Okay, maybe you could email me those. I'm curious. that's so exciting.

Sabrina (: 45:36

We did a lot of our earlier studies, what we call phase one in Australia or phase one two in Australia. We have a subsidiary there and we have some sites that we work with there. So it's just super efficient. And so the first thing we did, had women, you're all postmenopausal, about 30 women or so, and we had them use the product for just for one month. And at the end of study, they all wanted to keep using it.

Dr. Sameena Rahman (: 45:41

Yeah.

Dr. Sameena Rahman (: 45:47

Yeah.

Sabrina (: 46:02

And, you know, were like, well, no, we're not doing that. And technically we really didn't need to do another study because we got the data we needed for the one month study. But then they were so interested. so we went back and said, okay, you can all come back and we'll do a three month study and you can use it once a month, you know, every three months. And because it's been all months and so that looks, so we ended up doing that study really because the women, we had enough rings to do it. We had enough made and the women in Australia were really interested in it.

Dr. Sameena Rahman (: 46:08

Yeah. Yeah.

Dr. Sameena Rahman (: 46:22

Mm-hmm.

Dr. Sameena Rahman (: 46:30

Yeah.

Sabrina (: 46:32

So, bye.

Dr. Sameena Rahman (: 46:34

Awesome. I'm sure there's going to be a big pull for it. Because, you know, I think that that vaginal delivery that not thinking about, you know, ever changing, can I change my patch? do this? Like it's going to be big. I really think it's going to be big.

Sabrina (: 46:48

you hit on, I again, as I said this earlier, we're at Dari, we're primarily women designing for women. And you don't have to be, again, a rocket scientist to know like, it's hard when you're trying to manage my patch goes on at this schedule, but then I got to do my vaginal, you know, progesterone on this schedule, I'm using the Estrelal cream on these days, and I got to do my vaginal progesterone or my whatever, or, or I'm going to get an IUD to get my you know, it's a lot.

Dr. Sameena Rahman (: 47:07

Thank you.

Right.

Yeah, it's a lot. I feel bad asking. I feel bad asking the patients, you know, because I was like, I wouldn't do all the things I...

Sabrina (: 47:24

Again, all, know, we're also, you know, women tend to be, you know, kind of the managers of their households, right? We're, you know, we're dealing with a lot. Then we got to remember which day to do which thing. yeah, so some of the things we try to do as a company is just think about, let's be real, right? What is, I use that term real world solution. I mean it very broadly, like what really is going to work well in the real

Dr. Sameena Rahman (: 47:34

I'll see

Yeah.

Dr. Sameena Rahman (: 47:50

Exactly. is there going to be more than one estradiol dose?

Sabrina (: 47:56

We developed two different doses. I will say, and you'll see this in the publication, the lower dose just did not work as well. It got just to kind of the target levels. So right now we're really leaning towards only making the higher dose available because it was well tolerated from a side effect profile and just had much better achievement of the target levels that were.

Dr. Sameena Rahman (: 48:17

Yeah.

Dr. Sameena Rahman (: 48:24

awesome. Okay, are you gonna tackle testosterone?

Sabrina (: 48:30

It is definitely on my list. is 100 % on our list. It's on my to-do list. It's on our Dara to-do list. And in all seriousness, it's one where, again, I think it is shocking to me that how hard you healthcare providers have to work to get women testosterone that you feel.

Dr. Sameena Rahman (: 48:32

It's how I do it.

Dr. Sameena Rahman (: 48:37

I'm not going.

Dr. Sameena Rahman (: 48:45

it.

Dr. Sameena Rahman (: 48:51

crazy.

Sabrina (: 48:53

comfortable is a high quality, but then all the craziness they have to go through with trying to get the dose right, use 1 10th, 1 12th of the mail and don't get confused and all the calculations you go through to figure out the levels. so, I'd love your input right now. Like what we have been hearing is what would be really helpful is to have a topical formulation that is your target amount, right? And that we show

Dr. Sameena Rahman (: 49:04

Yeah.

Sabrina (: 49:22

systemically is getting to the target you want.

Dr. Sameena Rahman (: 49:23

to help.

I mean, kind of like the androfem in Australia, you the one that's now going to be offered in, you know, like that, that I used to before I would use the FDA improvements testosterone for my patients. routinely have my patients upload the prescription and they get it mailed from Australia. And then after the pandemic hit, I found that they were like some more delays. And then,

just the whole issue around testosterone and all the regulations. But for my patients loved it. It just turned out to be cheaper to do it this way, which is like FDA improvements testosterone because it was easier to access sometimes depending on the pharmacy. But I think if you could get that transdermal formulation that's just titrated for women, it'd be wonderful, which is like the endorphine.

Sabrina (: 50:01

with me.

Sabrina (: 50:16

We definitely think so. we're, you know, it's something we're looking at and for us as a company, we just, we have to be confident that, you know, we can make it in a way that makes sense. It's going to be reproducible and that it's hitting the medical targets, you know, that are needed. So you definitely get the need is the need is there.

Dr. Sameena Rahman (: 50:25

Thank

Dr. Sameena Rahman (: 50:33

Yeah, I'm sure. Anita's there. Anita's there. Awesome. Well, thank you, Sabrina. This has been amazing. So you talked about how this is a company that is publicly funded. We're going to put in our show notes if someone wants to be inspired to invest $10 or $10,000, whatever investment they can do.

Sabrina (: 50:38

100%.

Sabrina (: 51:00

Yep.

Dr. Sameena Rahman (: 51:02

Tell me a little bit how you came about that sort of discussion.

Sabrina (: 51:06

Yeah, so, you know, one of the things that we wanted to do, as I talked to, as we talked to women, healthcare providers, whoever, about what we're doing, invariably someone will say, oh my gosh, thank you so much, I would love to support your work. And, you know, how can I invest in your company to support that? Because, by the way, I mean, your listeners should know only 1 % of private investment

Dr. Sameena Rahman (: 51:21

I want to

Sabrina (: 51:33

that goes into developing new pharmaceutical products actually goes into companies like ours that are innovating solely for women, 1%. So it's hard to do a lot with like 1 % of dollars. And so people would come to us wanting to make a difference. But typically the irony is investment in a public company like ours is normally only available to those same people that have made a decision that they're only gonna allocate 1 % of their pot of money.

Dr. Sameena Rahman (: 52:01

Yeah. Yeah.

Sabrina (: 52:03

to the kind of work we're doing. And so I can't take credit for this. One day someone said to me, you need to figure out a way. I want to give Dara money, right? And I don't have a way to do that, right? I don't have a way to give Dara money, not as a donation, but I want to be an owner. And if you buy shares on the open market, you're actually not, I mean, you're owning our shares, but that money doesn't come to us.

So the only way the money comes to us to support the work is if we do what's called a public offering. So we found a way. We worked with the Securities and Exchange Commission. We worked with NASDAQ where we're listed because we said, we want to do this. It's a great idea. We want to do something so that anyone who cares about what we're doing can become an owner. It's not a donation. You're going to own shares. And $250 is the minimum. So $250 and a credit card, you can go as high as you

Dr. Sameena Rahman (: 52:51

Yeah.

Yes.

Sabrina (: 52:56

and can support the work and that is, you know, it's how this work happens.

Dr. Sameena Rahman (: 53:02

100%. Yeah, I think it's great. I feel like this is somebody, this is something that everyone, you know, that wants to make a difference, right? We all are like, what can we do to further women's health? You know, there's research, there's, you know, getting more equitable, you know, access to things. But this is one step, right? This is one step in the pie, because we have a lot of work.

Sabrina (: 53:25

It's, yeah, I always say, mean, there's the, you think about like really optimizing your health, there's a few pillars to that, right? One is information and prevention, right? One is like testing, right? Diagnosis and testing and, by again, which is, you know, so access and information. But then the other is once you figure out that there's a need, it's having a therapeutic, right? Having that solution, right? We need all of that.

Dr. Sameena Rahman (: 53:52

and all that. So here's solution and you guys can all join in. Amazing. Well, thank you, Sabrina. I love the work that you're doing. I'm super excited about all the products that you've mentioned, actually. I can't wait to try some of them myself. But otherwise, thanks for being on today. And we'll put in the show notes how people can find you or they want to do anything. But thanks for doing this. I it's amazing.

Sabrina (: 54:15

Thank you.

Sabrina (: 54:20

Oh my gosh, thanks for the conversation. Thank you so much. And thanks for what you are doing, right? To really be vocal and do all you're doing to remove the stigma.

Dr. Sameena Rahman (: 54:22

Yeah, no, course, no, no.

Dr. Sameena Rahman (: 54:34

No, we all have to do our part because at some point when we leave this world, we want to have some imprint. So it should be a positive one. So well, thanks so much, Again, thanks everyone for listening to Gyno Girl Presents Sex, Drugs, and Hormones. I'm Dr. Samina Rahman, Gyno Girl. Remember, I'm here to educate so you can advocate for yourself. Please join me next week. Yay.