The US Food and Drug Administration (FDA) has recently approved Annovera™ (The Population Council, Inc), the first long-acting combined hormonal vaginal ring contraceptive that can be used for an entire year.
Annovera is a donut-shaped, reusable, nonbiodegradable, white opaque, flexible vaginal ring containing two active ingredients: low doses of a novel progestin, Nestorone® (segesterone acetate), with a widely used estrogen (ethinyl estradiol).
It must be placed in the vagina for 3 weeks and then removed for 1 week during which women experience a withdrawal bleeding. Each ring releases approximately 0.15 mg/day of segesterone acetate and 0.013 mg/day of ethinyl estradiol over the 3 weeks period of active use.
The removed ring is cleaned with mild soap and warm water patted dry and placed in its case during the one-week dose-free interval. At the end of the dose-free interval, the vaginal system should be cleaned prior to being placed back in the vagina for 3 complete weeks cycle.
The schedule is repeated every 4 weeks for 1 year, covering 13 menstrual cycles of 28 days each.
Victor Crentsil, M.D., acting deputy director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research said in a press release, “The FDA is committed to supporting innovation in women’s health and today’s approval builds on available birth control options.”
The approval of Annovera is based on results of 17 clinical trials that include safety and efficacy data from three, open-label clinical trials which included 2,308 healthy women ranging from 18 to 40 years of age. Based on the results, Annovera was 97.3% effective in preventing pregnancy when used as directed.
The ring carries a boxed warning about the serious risk of a cardiovascular event in women who smoke and are over the age of 35. Annovera is contraindicated in women who are at high risk of arterial or venous thrombotic diseases, current or history of breast cancer or other estrogens- or progestin-sensitive cancers; liver tumors, acute hepatitis, or decompensated cirrhosis; undiagnosed abnormal uterine bleeding; hypersensitivity to any of the components of Annovera; and use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Most common side effects are similar to other combined oral contraceptives that include headache/migraine, nausea/vomiting, yeast infections, abdominal pain, dysmenorrhea (painful menstruation), breast tenderness, irregular bleeding, diarrhea and genital itching.
The FDA will further evaluate Annovera based on the results of post-marketing studies for risk of venous thromboembolism and the effects of CYP3A modulating drugs and tampon use on the pharmacokinetics of Annovera.
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. Under the terms of the license agreement, TherapeuticsMD will provide Annovera at 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.
