A new class of reversible birth control takes the shape of a reusable, doughnut-shaped silicone ring, with the FDA’s approval of the Annovera contraceptive developed by the Population Council.
The flexible ring is self-administered, placed within the vagina for three weeks at a time, and lasts for an entire year. It is washed and stored in a compact case when not in use during a four-week menstrual cycle and does not require refrigeration—which the international nonprofit sponsor says is important for its distribution and use in low-resource settings.
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.
“Nearly half of all pregnancies in the U.S. are unintended, which can increase health risks for mom and baby,” Population Council President Julia Bunting said following its approval last August. “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 prescription drug-device combination—containing the novel progestin hormone segesterone acetate, plus ethinyl estradiol—is the sixth contraceptive product developed by the Population Council globally, along with the copper intrauterine device ParaGard, as well as Mirena, Jadelle and others. Through its U.S. distribution partner TherapeuticsMD, the nonprofit plans to make Annovera commercially available late this year or in early 2020.
TherapeuticsMD recently presented phase 3 data on Annovera at the annual meeting of the American College of Obstetricians and Gynecologists. In addition to potent effects in preventing pregnancy, the contraceptive ring had a high level of user satisfaction, as it did not require a medical procedure for insertion and removal. Also, women who used Annovera for up to 13 cycles did not experience unexpected safety findings, the company said.
The ring carries an FDA boxed warning related to cigarette smoking and serious cardiovascular events, similar to other hormonal contraceptives. The agency is also requiring postmarket studies on the risk of venous thromboembolism, as well as the effects of tampon use and CYP3A modulating drugs on Annovera’s pharmacokinetics.