This is the third post in a series of three about birth control. It became apparent in Season One of the Fempower Health Podcast that there's a lot of questions and potential controversy about birth control.
I wanted to get an MD perspective and a period expert perspective. This last one is about innovation in birth control for you to consider. Here, I talk to Saundra Pelletier. Saundra sits at the head of Evofem Biosciences, a female- forward company revolutionizing women’s healthcare with game-changing products, including Phexxi, the first – and highly anticipated – hormone-free, prescription, on-demand female contraceptive gel.
Georgie Kovacs: Tell me about Phexxi.
Saundra Pelletier: It is the first and only non-hormonal birth control that women use on demand. You use it right before sex or up to an hour before; never after sex.
It has been decades, literally decades, since real innovation has come out in the category. And that agitates some people when I say it, because they're like, "Why would you say that Saundra? There are rings. There are patches." And I said, "Innovation is not just a lower dose of more hormones in a different delivery system." But innovation is something that's truly different.
So right now in the United States, half of all pregnancies are still unintended. So when you think about it, there's 18 categories of contraception. If the problem was solved, why are half of all pregnancies still unintended? Well, because women suffer from side effects.
So the real problem I was trying to solve was this. I know that women suffer in silence because we're raised to be pleasers and we're raised to be martyrs and we're supposed to kind of suck it up. And we don't talk to our male partners about our weight gain and our headaches and our bloating, because really that's not a very attractive conversation. So women talk to their friends, but their partners have no idea. I wanted women to feel as good as they could. So, that impacted everybody positively. Right?
When women feel good, everybody benefits.
I was on hormonal contraception for almost 20 years. I tried seven different products, because I never could really feel like myself and I couldn't figure it out. I knew the only thing that I was doing was ingesting synthetic hormone in my body everyday.
And did you know 700,000 women are diagnosed with cancer every year, not just breast cancer, all different kinds of cancer? After you have a cancer diagnosis, if you're still fertile, they are clinically responsible to make sure these women are on prescription birth control, because the last thing they want is for them to get pregnant and have all these other hormones circulating through their body. But right now the only product they can prescribe is a copper IUD. Now Phexxi is available as a solution for these women.
You have terrible vaginal dryness because all the hormones are out of your body. You have vaginal bleeding. You worry about your intimate relationship. You just do. Mine didn't survive. It didn't. And I hear that story from about a lot of women that their relationships don't survive. Phexxi is really an interesting solution for women who cannot or will not use a hormone.
There's 21 million women right now in the United States who are not using hormonal contraception right now. While, it was suggested to me that younger women weren't going to want this product because they wanted a fit and forget method. But this was not the case.
Young women said to me, "I was put on an anti-anxiety product. I was put on an antidepressant. But then when someone took the time to evaluate my body and my hormones and I was taken off these things, I felt normal again."
I asked them, "What about something on demand? Don't you think it's crazy that women are asked to take something every day of every week of every month of every year when they don't have sex every day?"
Do you think that a man would take something every day if he didn't even need it? No, that would not happen.
Georgie Kovacs: How does Phexxi work?
Saundra Pelletier: You can take an applicator and put it in your purse. A prescription is a box of 12 prefilled applicators. You don't have to leave it in the package, but you can take it out, put it in your purse or pocket.
You put it in right before intercourse or up to an hour before.
Most women have a pH of 3.5 to 4.5. When semen enters, the pH rises. That's how you get pregnant. What Phexxi does is it's acid buffering and it just helps you maintain your normal vaginal pH. So it's inhospitable to semen.
We are not going to use something that leaks out, right. It's very viscous and bioadhesive.
Georgie Kovacs: What feedback have you heard from users about it being on-demand? Doesn't ruin the mood?
Saundra Pelletier: There's subsets of women, in my opinion, about intimacy and ruining the moment of interruption of intimacy.
There's the women that say to us that they always go to the restroom right before, because they want to pee. They pee and then put in Phexxi. They either put it back in their bag or empty the applicator or throw it in the trash. Nobody knows; it's discreet. It is a little bit like contact lenses. The first time or two, it's a little awkward. And then once you get used to it, you're like, "Wow, this is so easy."
Then there's a group of women that say they're using lubricants already as part of intimacy so their partner knows. They think it's all sensual and sexy and it's all fine because they're super comfortable. One of these women said to me, "Look, I have sex with the lights on. I'm happy to put in Phexxi, which is great.
Then there's the group that's saying, "Yeah, I can't. I can't do it now. I can't go there. I can't, I can't.' And by the way, I also get that product and I really need this. It's not for everyone.
Georgie Kovacs: Tell us about Phexxi and STDs/STIs because we are taught about the importance of condoms.
Saundra Pelletier: We do say that it will say on our label that you still need to use condoms for prevention of STDs or STI and HIV prevention.
Georgie Kovacs: Tell us about the ingredients in Phexxi and women’s tolerance.
Saundra Pelletier: They are lactic acid, citric acid and potassium bitartrate and we had less than 2% of women discontinue due to side effects while a lot of these ingredients.
Georgie Kovacs: Can Phexxi be put inside a condom and be as effective?
Saundra Pelletier: We didn't study it that way. So here's what I would say. Our clinical study was women using the applicator within the label, meaning, right before sex up to an hour, not after. So because we didn't study it that way, I wouldn't be able to say that.
At one point there were a lot of spermicide other products that coated condoms on the outside. And at one point when I first joined the company, the previous team, which were all men, were looking at coating condoms instead of coming to market as a contraceptive product for women. But fortunately we were able to persuade them that coming to market for women and truthfully, I wanted women to be in control, right?
Georgie Kovacs: Do you have a trial or anecdotal information around what you've heard from the consumer around the impact on men?
Saundra Pelletier: We had 1400 women in phase three clinical study for Phexxi. So we did get feedback from real partners of real women who were in the study. There's no odor to it, so that was perceived as very positive.
Georgie Kovacs: Did your studies have any endpoints around the rarity of STDs?
Saundra Pelletier: We didn't have any endpoints around that in the contraceptive study. However, when we did our first phase three study years ago, not this recent Phase Three Phexxi study, but the first one we had to do. It was a comparison against a nonoxynol-9 product, which is a surfactant.
Nonoxynol-9 has a black box warning in the U S it's been banned in a lot of the world because the ingredients are like a detergent. And the reason that does tear at the epithelial lining of the vaginal cavity, because our ingredients are very different - lactic acid, citric acid, sodium bitartrate. Yes. We obviously don't have a black box warning. And because less than 2% of patients discontinue, it was deemed as being a safe, well tolerated product.
Georgie Kovacs: How did you decide to make this a prescription rather than over the counter product?
Saundra Pelletier: So we did market research around mindset. In market research, it was resounding that women had a mindset that if they were doing something as serious as protecting themselves from getting pregnant, that the majority of women felt like they wanted it to be FDA approved. They wanted the clinical rigor being at the second with Obamacare, the Affordable Care Act category of contraception is covered. So we are the only vaginal pH regulator or the only non-hormonal gel. So the majority of plans do zero out of pocket pay. So if you go over the counter, you're clearly paying out of pocket.
We've been very successful. We have 60% of lives covered. So we thought that women would have more access at lower prices if it was prescription.
And to be candid, the over-the-counter market is very, very small. So for the investment we made into development, which was $150 million, we knew that what we wanted was to, and by the way, the payers even said to us, “As long as you charge us what we pay for branded pills, we're not going to give you any step edits. We're not going to block you as long as you stay within that range.” And that range was somewhere between $200, $275 a month. So yeah, so we felt like it was a win-win, you know, women won't have to pay as much as women are going to have access.
They perceive that we did the clinical rigor of a real study with the FDA. And so that's why we decided to be a prescription.
Georgie Kovacs: To be clear so that women don't miss it, is it still covered? So the $275 isn't necessarily what they're paying. That was more of what the payer pays.
Saundra Pelletier: We have a program where women are getting the first month free - $0. And then if they have a health care plan, they're getting either $0, or what we've seen is up to $30 somewhere between zero and $30 women are paying. So that's why we feel really good. And 60% coverage, we're continuing to have very big wins. We're Medicaid. We have a big contract with the VA and we are continuing to get the big plans, like the blues and all these big places, 60% plus VA plus Medicaid so far.
Georgie Kovacs: What would be your greatest hope for women's health and what are your future plans that you can publicly disclose?
Saundra Pelletier: My greatest hope for women's health is that there are more women CEOs running women's healthcare companies. I really believe it matters. I see it in my own experience. My ability to talk about why this product is important - and most of our investors are all male, the majority of them. I say to them, “You don't have to take my word for it, but please talk to your wife or your girlfriend or your significant other, and think about your daughter. I know you guys think that birth control isn't important, but think about the responsibility of managing fertility all those years have put on the woman.”
For Evofem, my wish and my goal is that we are really seen and embraced by women in a way that shocked the hell out of the entire investment community and the entire pharma community. I want them to see Evofem as a company that innovates for women that is about women that want to take the shame out of sexuality.
Georgie Kovacs: I think it's going to happen. I interviewed Dr. Lara Briden, she's in New Zealand and she is quite a badass. She wrote a book called Period Repair Manual, and it was only published like five or six years ago. She said that when she was publishing it, there was debate on whether she could put the word "period" on the cover. Now people say “period” all the time. So I do think your hope is realistic.
I guess it takes people like you and it's working. So thank you.
Saundra Pelletier: Thank you back. I love you for saying that. I believe in these three C's, right? CONFIDENCE. COMFORT. CREDIT for women. There is this fine line as you know, between being assertive and being aggressive. Being arrogant and being competent. And that the tough part is that women have been given the wrong messages, but it is our intuition and ability to have a high EQ. Women have these wonderful gifts that we know about, but we don't use them enough.
Thank you so much for taking your time for me. I really appreciate it. And I really hope I want to stay connected and nice to meet you.
About Saundra Pelletier
Saundra Pelletier is a mother, daughter, CEO and trailblazer. Undoubtedly and unapologetically, Saundra is one of the most dynamic women in today’s healthcare industry. She sits at the head of Evofem Biosciences, a female- forward company revolutionizing women’s healthcare with game-changing products, including Phexxi, the first – and highly anticipated – hormone-free, prescription, on-demand female contraceptive gel.
But her impact transcends her executive title and illustrious resumé.
At her core, Saundra is a passionate advocate for women’s wellness and empowerment. She is a leader in the boardroom and beyond, using her experience, voice and vision for real, progressive change for women. Saundra is a force of energy that blends substance and excitement with straight talk and strong opinions. Never mind being a breast cancer survivor who fought the illness as she remained solidly at the helm of Evofem, securing $400+ million and achieving FDA approval. All while raising a son as a single mother.
Once you meet Saundra Pelletier, you won’t forget her. You won’t want to.
About Fempower Health and Its Founder
Georgie is the founder and host of the Fempower Health podcast, a top 10 women’s health podcast with 5 stars on Apple. She is an advocate leveraging her 20+ years in healthcare and personal fertility journey to transform women’s healthcare, answering your health questions. She brings on top experts in women’s health with the aim of educating women about their bodies to have more empowered (and speedy) health journeys.
Follow Fempower Health on Instagram for the latest in women’s health.
Do not use Phexxi. If you have problems with your urinary tract or a history of repeated UTIs, vaginal burning, itching, infection, and discharge, UTI genital area discomfort, bacterial vaginosis, or pain while urinating may occur for information about Phexxi, talk to your doctor and see product firstname.lastname@example.org.