TherapeuticsMD Announces FDA Approval of ANNOVERA™ (Segesterone Acetate/Ethinyl Estradiol Vaginal System) for Birth Control

TherapeuticsMD, Inc. (NASDAQ:TXMD), an innovative women’s healthcare company, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved ANNOVERA™ (segesterone acetate/ethinyl estradiol vaginal system), the first long-acting prescription birth control that is patient-controlled, procedure-free and reversible. The ANNOVERA contraceptive vaginal system is a small, soft flexible ring that prevents ovulation for an entire year (13 cycles) and can be inserted and removed by a woman at her discretion in repeated four-week cycles (remaining in place continuously for three weeks followed by removal for one week).

The segesterone acetate component of the ANNOVERA contraceptive vaginal system is expected to be classified as a new chemical entity, or NCE, by the FDA and thus will likely be entitled to five years of regulatory exclusivity under the Drug Price Competition and Patent Term Restoration Act of 1984, otherwise known as the Hatch-Waxman Act. This unique contraceptive vaginal system technology combines low doses of a novel progestin, Nestorone^® (segesterone acetate), with a widely used estrogen (ethinyl estradiol). The contraceptive vaginal system works by releasing an average continuous daily dose of 0.15 mg/day of segesterone acetate and 0.013 mg/day of ethinyl estradiol to prevent pregnancy.

“The U.S. contraceptive market is shifting toward long-acting solutions and we believe ANNOVERA represents an exciting new entrant for women and healthcare providers by providing the first woman-controlled, procedure-free, long-acting, reversible birth control product putting the woman in control of both her fertility and menstruation,” said Dr. Brian Bernick, Co-Founder of TherapeuticsMD. “We believe ANNOVERA can help meet the needs of women who are looking for long-acting solutions, including women who have never given birth and women who are not in a monogamous relationship, who are often counseled not to use many of the currently available long-acting contraceptive products.”

ANNOVERA was developed by the global non-profit research organization, Population Council, a leading developer of long-acting, reversible contraceptives. The FDA approval of ANNOVERA is based in part on data from 17 clinical trials, including safety and efficacy data from three open-label trials that included 2308 healthy women in total. The data showed that ANNOVERA was 97.3 percent effective in preventing pregnancy when used as directed – making it among the most effective women-controlled methods of contraception. Based on pooled data from the two trials of 2111 females ≤35 years of age, the primary endpoint Pearl Index (PI) was 2.98 per 100 woman-years of ANNOVERA use. Results from the Phase 3 acceptability sub-study of 905 women support an overall satisfaction rate of 89 percent, which was related to ease of use, side effects, expulsions/feeling the product and effects during sexual activity. The trials also demonstrated high rates of adherence and continuation for a full year. The most common adverse reactions leading to discontinuation by ≥ 1 percent of ANNOVERA-treated women included irregular bleeding (metrorrhagia/menorrhagia) (1.7 percent), headache/migraine (1.3 percent), vaginal discharge/vulvovaginal mycotic infections (1.3 percent), and nausea/vomiting (1.2 percent). Consistent with other combination hormonal contraceptives (CHCs), cigarette smoking increases the risk of serious cardiovascular events from CHC use. Women over 35 years old who smoke should not use ANNOVERA. Also consistent with other CHCs, women are at increased risk for a venous thrombotic event (VTE) when using the one-year contraceptive vaginal system. Limited data are available in women with a Body Mass Index (BMI) greater than 29 kg/m² because this population was excluded from the clinical trials after VTEs were reported. A post-approval observational study will be performed to measure the risk of venous thromboembolism. Important safety information for ANNOVERA, including the boxed warning, is provided below.

“ANNOVERA’s approval and designation as a ‘vaginal system’ potentially creates a new class of contraception that private health plans will be required to cover with no patient out-of-pocket costs under the Affordable Care Act (ACA),” said Robert Finizio, TherapeuticsMD CEO and Co-Founder. “TherapeuticsMD intends to leverage its existing infrastructure to commercialize ANNOVERA. Together with our prescription menopausal hormone products and prenatal vitamins, TherapeuticsMD aims to become the premier women’s healthcare company, offering a full portfolio of products across the woman’s lifespan from contraception and pregnancy through menopause.”

The U.S. market for prescription contraceptives generated more than USD 5 billion in net sales in 2017.An estimated 43 million women in the United States of America are at risk of unintended pregnancy of which 18 million women want to avoid pregnancy and nearly half of all pregnancies that occur each year in the United States of America are unintended. According to the National Center for Health and Statistics, use of long-acting reversible contraceptives increased nearly 5-fold in the last decade among women aged 15–44.

TherapeuticsMD intends to leverage the Population Council’s existing relationships with the supplier of segesterone acetate and the manufacturer of the clinical trial supply of the one-year contraceptive vaginal system to scale-up commercial manufacturing of ANNOVERA. TherapeuticsMD currently estimates that ANNOVERA will be commercially available as early as the third quarter of 2019 with the commercial launch as early as the fourth quarter of 2019 or first quarter of 2020. The ACA mandates that private health plans provide coverage with no out-of-pocket costs for one treatment per class of in each of the classes identified by the FDA for women in its Birth Control Guide. As part of its license agreement with the Population Council, TherapeuticsMD has agreed to provide significantly reduced pricing to federally designated Title X family planning clinics serving lower-income women.-Medical Buyer Bureau