The Food and Drug Administration (FDA) has approved Annovera (segesterone acetate and ethinyl estradiol vaginal system; TherapeuticsMD), a new combined hormonal contraceptive intended to prevent pregnancy. This approval marks the first reusable vaginal ring contraceptive that can be used for a whole year.
Annovera combines segesterone, a new progestin, with ethinyl estradiol, an estrogen. It is a soft, donut-shaped, non-biodegradable, and flexible silicone vaginal ring that is inserted in the vagina for 3 weeks followed by removal for 1 week. The vaginal ring releases an average continuous daily dose of 0.15mg/day segesterone acetate and 0.013mg/day of ethinyl estradiol. This schedule is repeated every 4 weeks for 1 year, which is equivalent to thirteen 28-day menstrual cycles. Also, the vaginal ring does not require refrigeration prior to dispensing and can be washed and stored in a compact for the 7 days it is not in use.
The safety and efficacy of Annovera was evaluated in 3 open-label clinical trials involving healthy women (ages 18 to 40). Results showed that Annovera was 97.3% effective in preventing pregnancy when used as directed; based on pooled data from 2 trials (N=2,111; ≤35 years of age), the primary endpoint Pearl Index was 2.98 per 100 woman-years of use. The most frequently reported adverse events were headache/migraine, nausea/vomiting, yeast infections, abdominal pain, dysmenorrhea, tender breasts, irregular bleeding, diarrhea, and genital itching.
The FDA is requiring post-marketing studies to evaluate the risk of venous thromboembolism (VTE) and the impact of CYP3A modulating drugs and tampon use on the pharmacokinetics of Annovera. According to the Company, a post-approval observational study will be performed to assess the risk of VTE. The product has not been adequately evaluated in females with a BMI of >29 kg/m2.
Annovera was developed by the global nonprofit organization The Population Council, Inc. TherapeuticsMD is expecting to launch Annovera sometime in the 3rd or 4th quarter of 2019 or the first quarter of 2020.
For more information visit TherapeuticsMD.com.