SILVER SPRING, Md., Aug. 10, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), which is a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year. Annovera is a reusable donut-shaped (ring), non-biodegradable, flexible vaginal system that is placed in the vagina for three weeks followed by one week out of the vagina, at which time women may experience a period (a withdrawal bleed). This schedule is repeated every four weeks for one year (thirteen 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," states Victor Crentsil, M.D., acting deputy director of the Office of Drug Evaluation III in FDA's Center for Drug Evaluation and Research.
Annovera is washed and stored in a compact case for the seven days not in use. Annovera does not require refrigeration prior to dispensing and can withstand storage temperatures up to 30°C (86°F).
The efficacy and safety of Annovera were studied in three, open label clinical trials with healthy women ranging from 18 to 40 years of age. Based on the results, about two to four women out 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 and serious cardiovascular events. Women over 35 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:
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 (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 granted approval of Annovera to The Population Council, Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, and products that give off electronic radiation, and for regulating tobacco products.
Media Inquiries:Theresa Eisenman, 301-796-2969, [email protected] Consumer Inquiries: 888-INFO-FDA