FDA Clears First Vaginal Ring for 1 Year of Birth Control

Megan Brooks

Disclosures

August 10, 2018

The US Food and Drug Administration (FDA) has approved segesterone acetate and ethinyl estradiol vaginal system (Annovera, The Population Council, Inc) — the first vaginal ring contraceptive that can be used for an entire year to prevent pregnancy.

"The FDA is committed to supporting innovation in women's health and today's approval builds on available birth control options," Victor Crentsil, MD, acting deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, said in an agency news release.

Annovera is a reusable, nonbiodegradable, flexible vaginal ring placed in the vagina for 3 weeks and then removed for 1 week during which women experience a menstrual period. The schedule is repeated every 4 weeks for 1 year, covering 13 menstrual cycles of 28 days each.

The efficacy and safety of Annovera were studied in three open-label clinical trials with healthy women ranging in age from 18 to 40 years. Based on the results, about two to four women out of 100 may get pregnant during the first year they use Annovera, the FDA said.

Annovera carries a boxed warning relating to cigarette smoking and serious cardiovascular events. Women aged over 35 years who smoke should not use Annovera. Cigarette smoking increases the risk for serious cardiovascular events from combination hormonal contraceptive use.

Annovera is contraindicated in women with a high risk for arterial or venous thrombotic diseases; current or history of breast cancer or other estrogen- 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.

The most common side effects in women using Annovera are similar to those of other combined hormonal contraceptive products and include headache/migraine, nausea/vomiting, yeast infections, abdominal pain, dysmenorrhea, breast tenderness, irregular bleeding, diarrhea, and genital itching.

The FDA will require postmarketing studies to evaluate the risk for venous thromboembolism and the effects of CYP3A modulating drugs and tampon use on the pharmacokinetics of Annovera.

The Population Council has entered into a license agreement with TherapeuticsMD to make Annovera available to women in the United States. As part of the license agreement, TherapeuticsMD will provide significantly reduced pricing to federally designated Title X family planning clinics serving lower-income women.

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