FDA News

FDA approves 1-year vaginal ring contraceptive

The FDA today approved a Annovera, a combined hormonal contraceptive for women of reproductive age and the first vaginal ring contraceptive that can be used for an entire year, according to a press release from the agency.

Annovera (segesterone acetate and ethinyl estradiol vaginal system; The Population Council, Inc.), is a reusable, 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 period (a withdrawal bleed). This schedule is repeated every 4 weeks for 1 year (for 13, 28-day menstrual cycles).

“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 FDA’s Center for Drug Evaluation and Research, said in the release.

Annovera is washed and stored in a compact case for the 7 days not in use. Annovera does not require refrigeration prior to dispensing and can withstand storage temperatures up to 86 degrees F.

The approval follows three open-label clinical trials with healthy women ranging from age 18 to 40 years. Based on the results, about two to four out of 100 women may get pregnant during the first year they use Annovera, according to the FDA.

The FDA cautioned that all hormonal contraception carries serious risks. Annovera has a Boxed Warning relating to cigarette smoking and serious cardiovascular events. Women over age 35 years who smoke should not use Annovera. 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 high risk for arterial or venous thrombotic diseases, a current or history of breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors, acute hepatitis, or severe (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 (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.

The FDA today approved a Annovera, a combined hormonal contraceptive for women of reproductive age and the first vaginal ring contraceptive that can be used for an entire year, according to a press release from the agency.

Annovera (segesterone acetate and ethinyl estradiol vaginal system; The Population Council, Inc.), is a reusable, 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 period (a withdrawal bleed). This schedule is repeated every 4 weeks for 1 year (for 13, 28-day menstrual cycles).

“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 FDA’s Center for Drug Evaluation and Research, said in the release.

Annovera is washed and stored in a compact case for the 7 days not in use. Annovera does not require refrigeration prior to dispensing and can withstand storage temperatures up to 86 degrees F.

The approval follows three open-label clinical trials with healthy women ranging from age 18 to 40 years. Based on the results, about two to four out of 100 women may get pregnant during the first year they use Annovera, according to the FDA.

The FDA cautioned that all hormonal contraception carries serious risks. Annovera has a Boxed Warning relating to cigarette smoking and serious cardiovascular events. Women over age 35 years who smoke should not use Annovera. 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 high risk for arterial or venous thrombotic diseases, a current or history of breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors, acute hepatitis, or severe (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 (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.