The Population Council, a global nonprofit research organisation, announced it has received U.S. Food and Drug Administration (FDA) approval for Annovera “the first vaginal ring contraceptive that can be used for an entire year.”
Annovera is the first in a new class of contraceptives. It is a soft, reusable, flexible silicone ring that can be inserted and removed by a woman herself. Left in place for 21 days and removed for 7 days each cycle where the woman will have a withdrawal bleed, 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.
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. Providing women with a range of contraceptive options that better meet their family planning needs helps reduce unintended pregnancy and improves outcomes.
The FDA approval of Annovera is based in part on data from 17 clinical trials, including two pivotal Phase 3 safety and efficacy trials. The Phase 3 program enrolled a total of 2,308 women across 27 study sites in the United States, Latin America, Europe, and Australia. Women in the trials were between 18 and 40 years of age and were instructed to use the system over 13 menstrual cycles, or one full year. The data show that Annovera is 97.3% effective in preventing pregnancy when used as directed.
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 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.
Population Council President, Julia Bunting said, “For more than 60 years, the Population Council has been at the vanguard of global efforts to develop innovative family planning methods that meet women’s needs. 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.”