New Vaginal Ring Earns FDA Approval for a Year of Birth Control

The FDA has approved The Population Council’s segesterone acetate and ethinyl estradiol vaginal system (Annovera), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy. The approved product is the first vaginal ring contraceptive that can be used for an entire year.

Annovera is a reusable donut-shaped, non-biodegradable, flexible vaginal system that is placed in the vagina for 3 weeks followed by 1 week out of the vagina, at which time women may experience a withdrawal bleed. This schedule is repeated every 4 weeks for 1 year, during 13 menstrual cycles of 28 days each.

“The FDA is committed to supporting innovation in women’s health and today’s approval builds on available birth control options,” said Victor Crentsil, MD, acting deputy director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research, in a prepared statement.

The approved contraceptive system is washed and stored in a compact case for the 7 days that it is not in use. The system does not require refrigeration prior to dispensing and can withstand storage temperatures up to 86°F.

The efficacy and safety of the segesterone acetate and ethinyl estradiol vaginal system were studied in 3, open label clinical trials with healthy women ranging in age from 18 to 40 years. Based on the results, about 2 to 4 of 100 women may get pregnant during the first year they use Annovera.

All hormonal contraception carries serious risks. Annovera carries a boxed warning relating to cigarette smoking, as well as serious cardiovascular events. Women over age 35 who smoke should not use Annovera, the FDA reports. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use.

Annovera is contraindicated and should not be used in women with:

• A high risk of arterial or venous thrombotic diseases;
• Current or history of breast cancer or other estrogen- or progestin-sensitive cancer;
• Liver tumors, acute hepatitis, or severe 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 adverse effects in women using the newly approved contraception system are similar to those of other combined hormonal contraceptive products and include headache/migraine, nausea/vomiting, yeast infections, abdominal pain, painful menstruation, breast tenderness, irregular bleeding, diarrhea, and genital itching.

The FDA is requiring postmarketing studies to further evaluate the risks of venous thromboembolism, and the effects of CYP3A modulating drugs and tampon use on the pharmacokinetics of Annovera.

Reference

FDA approves new vaginal ring for one year of birth control [news release]. Silver Spring, MD; August 10, 2018: FDA website. http://www.pharmacytimes.com/link/202. Accessed August 10, 2018.