FDA approves Annovera first one year contraceptive.- The Population Council + TherapeuticsMD.

The Population Council, a global nonprofit research organization, announced it has received FDA approval for Annovera (segesterone acetate and ethinyl estradiol vaginal system), the first and only contraceptive that provides an entire year of protection against unintended pregnancy while fully under a woman�s control. The approval marks an important step toward expanding contraceptive options for women.

Annovera is the first in a new class of contraceptives. It is a soft, reusable flexible silicone ring (2 � inches diameter) that can be inserted and removed by a woman herself. Left in place for 21 days and removed for 7 days, it is indicated to prevent pregnancy for up to a year and does not require refrigeration, which is particularly important for distribution and use in low-resource settings. Annovera has not been adequately evaluated in women with a body mass index (BMI) greater than 29 kg/m2.

In formulating Annovera, researchers at the Population Council�s Center for Biomedical Research combined a new progestin (segesterone acetate) with a widely used estrogen (ethinyl estradiol) to develop a single product that can inhibit ovulation for an entire year. A sub-set study of women in the Phase 3 clinical trials ranked Annovera highly in terms of convenience, ease of use, and comfort. Nearly 9 in 10 women (89%) surveyed were satisfied with it as a method of contraception. Most participants surveyed experienced no change in sexual pleasure or frequency of sexual intercourse.

Recently, the Population Council announced a license agreement with TherapeuticsMD, an innovative healthcare company focused exclusively on women�s health, to make Annovera available to women in the U.S. Through the license agreement, TherapeuticsMD will provide significantly reduced pricing to federally designated Title X family planning clinics serving lower-income women. TherapeuticsMD currently estimates Annovera will be commercially available as early as the third quarter of 2019 and commercially launched as early as the fourth quarter of 2019 or first quarter of 2020. Proceeds from the license agreement will be reinvested into the Population Council�s continued research and development programs. The Population Council is continuing efforts to make Annovera available worldwide, including in low- and middle-income countries where more than 214 million women have an unmet need for contraception.