The FDA approved the first in a new class of self-administered hormonal contraceptives, formed as a reusable, flexible silicone ring that is placed in the vagina for three weeks at a time for up to an entire year.
Developed by the Population Council, Annovera (segesterone acetate and ethinyl estradiol) is washed and stored in a compact case for the seven days it's not in use during a four-week menstrual cycle. It does not require refrigeration, which the international nonprofit says is important for distribution and use in low-resource settings, and it can withstand storage temperatures up to 86°F (30°C).
“Nearly half of all pregnancies in the U.S. are unintended, which can increase health risks for mom and baby,” said Population Council President Julia Bunting in a statement. “Having a single contraceptive system that provides a full year of protection while under a woman’s control could be a game-changer for some women.”
Women with unintended pregnancies are less likely to receive proper prenatal care, are more likely to have premature and low-birth-weight infants and have increased physical and mental health risks, the council said.
“The FDA is committed to supporting innovation in women’s health and today’s approval builds on available birth control options,” said Victor Crentsil, M.D., acting deputy director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research.
Annovera was studied in three open-label trials with healthy women 18 to 40 years of age. About two to four women out of 100 may get pregnant during the first year they use Annovera as directed, the FDA said.
The agency said women over 35 who smoke should not use Annovera, and the ring carries a boxed warning relating to cigarette smoking and serious cardiovascular events, similar to other hormonal contraceptives.
In addition, the FDA is requiring postmarket studies on the risk of venous thromboembolism and the effects of tampon use and CYP3A modulating drugs on Annovera’s pharmacokinetics.
Annovera is the sixth contraceptive developed by the Population Council globally, along with the copper intrauterine device ParaGard, as well as Mirena, Jadelle and others. The nonprofit, through its U.S. distribution partner TherapeuticsMD, currently expects to make Annovera fully commercially available in late 2019 or early 2020.
Its development was supported by public and private contributors including USAID, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the Bill & Melinda Gates Foundation, the Avis and Clifford Barrus Medical Foundation and the World Health Organization.