Why I started a pharmaceutical company

September 8, 2020

Published as a promotional supplement to Contemporary OB/GYN.

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Sponsored by: TherapeuticsMD

Many people ask me how and why I started TherapeuticsMD. The simple answer to why is that, like many of my colleagues, I was frustrated by current therapies in women’s health that were antiquated and by the lack of innovation in commonplace treatments for contraception and menopause.

Having spent the last 25 years focused on women’s health, I used my personal experience as an obstetrician-gynecologist, along with the collective feedback of my fellow healthcare providers and our patients, to create and bring to market new products like Bijuva (estradiol and progesterone) capsules, Imvexxy (estradiol vaginal inserts), Annovera (segesterone acetate and ethinyl estradiol vaginal system), and our vitaMedMD prenatal vitamins with the goal of answering the needs of our patients with modern solutions that fit their lifestyles.

Practicing in South Florida, I had the opportunity to take care of many menopausal women. Then, in 2002, the initial news from the landmark Women’s Health Initiative (WHI) study suggested that synthetic hormones increased the risk of breast cancer, stroke, heart attack, and blood clots.1

This finding was in contrast to what many healthcare providers were recommending to women based on the general belief that hormones were good for their heart, brain, and bones and that they should stay on them indefinitely. Unfortunately, all US Food and Drug Administration (FDA)-approved combination hormone products for postmenopausal conditions contained a synthetic progestin.

After WHI, I observed that most women and healthcare providers shifted to hormone therapy containing bioidentical estradiol and bioidentical progesterone because they believed this was a better alternative.2

The lone FDA-approved progesterone, however, was only studied and approved as 200 mg for 12 nights sequentially in combination with 0.625 mg of conjugated estrogen, yet many healthcare providers began prescribing it as 100 mg daily with any amount or form of estrogen.3

As an evidence-based practitioner, I was concerned about endometrial safety with this approach, based on the results of small studies that showed endometrial hyperplasia. I struggled with the reality that no combination of estradiol and progesterone, whether oral or transdermal, had been studied in a randomized, placebo-controlled trial and FDA approved to be used together.

Moreover, I was alarmed that there were no efficacy or safety data supporting compounded bioidentical hormones that had become the standard of care based on prescription volume here in the United States.2

The importance of this is significant because the risk to the endometrium represents the greatest risk to a woman when using hormone therapy. The background incidence of endometrial hyperplasia in a non-hormone user is 1% (1/100), which increases significantly when estrogen therapy is not adequately opposed by a progestogen.4

Like many of my colleagues, I had a preference for transdermal estrogen because it conveys a small reduction in the venous thromboembolism (VTE) risk from oral estradiol and micronized progesterone (1.5 vs 1.2–3 per 1000 woman-years).5-7 That, however, was trading a lower risk of VTE for a 10-fold higher risk of endometrial hyperplasia/cancer without robust data for the unapproved regimen of transdermal estradiol with progesterone in women with a uterus.3

Moreover, I was frustrated by the confusion among my colleagues and our patients regarding the risks of hormone therapy as these particularly relate to breast cancer and cardiovascular disease, especially after the reanalysis of WHI and subsequent studies. As such, I set out to address these concerns and develop the first and only FDA-approved hormone therapy combination of estradiol and micronized progesterone that would be rigorously studied in a large phase 3, randomized, placebo-controlled trial.4

Further, I was troubled by the fact that many of my menopausal patients suffered from symptoms of vulvar and vaginal atrophy, yet too few of them would try or stay on treatment. It is estimated that vulvar and vaginal atrophy occurs in more than 1 out of 2 menopausal women, but only 7% of women are treated with prescription hormone therapy.8

I recognized that my patients and fellow healthcare providers were looking for treatments that were easy to use and not messy to administer, and worked quickly in low doses with limited systemic exposure. I then set out to address these concerns and develop an applicator-free, rapidly dissolving softgel vaginal insert containing ultra-low doses of 17β-estradiol.

I also partnered with the Population Council, a not-for-profit organization founded by John D. Rockefeller, III, with a focus on reproductive health. The Population Council was the initial developer of the world’s long-acting reversible contraceptives, including the 10-year copper intrauterine device (IUD), the original 5-year levonorgestrel IUD, and the contraceptive implant. More than 170 million women worldwide use contraceptive technologies developed by the Population Council.

The Population Council recognized, however, that despite the importance of long-acting reversible contraception, all too often women declined the options because these required a procedure for insertion and removal. Accordingly, they developed a contraceptive that does not require a procedure for insertion or removal and provides women with long-lasting efficacy for 1 year (13 cycles).9

This contraceptive is now part of the TherapeuticsMD product portfolio and supports our commitment to deliver a selection of modern products for women throughout the different stages of their lives. Likewise, to complement these products, I created a line of prescription prenatal vitamins with options for all types of women’s preferences.

Finally, as a community healthcare provider for many years, I understand that affordability is one of the most important considerations for our patients. This has led me to instill within our organization the principle of making certain that cost should not be a barrier to any woman using our products.

Starting a pharmaceutical company is not easy. It takes many years of experimentation and development, millions if not billions of dollars, and a lot of luck. Several clinical trials were conducted all over the United States and throughout the world to support our products. I am fortunate to have had people believe in these opportunities and be willing to invest their money and experience in helping me along the way.

I truly feel that what we have accomplished is the result of the collective input and experience of my fellow healthcare providers and the women we treat. I am humbled to have played a role in helping to bring more attention and treatment options to women’s health.

For product information and Full Prescribing Information, including BOXED WARNINGS, visit TherapeuticsMD.com/products.

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Author Biography

Brian A. Bernick, MD, FACOG, is a board-certified obstetrician-gynecologist and co-founder and chief scientific officer of TherapeuticsMD, Inc. He is also a clinical affiliate associate professor at Florida Atlantic University Charles E. Schmidt College of Medicine in Boca Raton.

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References

  1. Rossouw JE, Anderson GL, Prentice RL, et al. Risks
    and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA. 2002;288(3):321-333.
  2. Pinkerton JV, Santoro N. Compounded bioidentical hormone therapy: identifying use trends and knowledge gaps among US women. Menopause. 2015;22(9):926-936.
  3. Mirkin S, Goldstein SR, Archer DF, et al. Endometrial safety and bleeding profile of a 17β-estradiol/progesterone oral softgel capsule (TX-001HR). Menopause. 2020;27(4):410-417.
  4. Lobo RA, Archer DF, Kagan R, et al. A 17β-estradiol-progesterone oral capsule for vasomotor symptoms in postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2018;132(1):161-170.
  5. Simon JA. What if the Women’s Health Initiative had used transdermal estradiol and oral progesterone instead?Menopause. 2014;21(7):769-783.
  6. American College of Obstetricians and Gynecologists. ACOG committee opinion no. 556: postmenopausal estrogen therapy: route of administration and risk of venous thromboembolism. Obstet Gynecol. 2013;121(4):887-890.
  7. Canonico M, Fournier A, Carcaillon L, et al. Postmenopausal hormone therapy and risk of idiopathic venous thromboembolism: results from the E3N cohort study. Arterioscler Thromb Vasc Biol. 2010;30(2):340-345.
  8. Kingsberg SA, Krychman M, Graham S, et al. The Women’s EMPOWER survey: identifying women’s perceptions on vulvar and vaginal atrophy and its treatment. J Sex Med. 2017;14(3):413-424.
  9. Nelson AL. Comprehensive overview of the recently FDA-approved contraceptive vaginal ring releasing segesterone acetate and ethinylestradiol: a new year-long, patient controlled, reversible birth control method. Expert Rev Clin Pharmacol. 2019;12(10):953-963.