The device is a round donut-shaped 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). The schedule is repeated every four weeks for one year (thirteen 28-day menstrual cycles).
“Nearly half of all pregnancies in the U.S. are unintended, which can increase health risks for mom and baby,” said Julia Bunting, president of the Population Council, a non-profit organization that works on reproductive issues worldwide, in a news release. “Having a single contraceptive system that provides a full year of protection while under a woman’s control could be a game-changer for some women.”
According to the Centers for Disease Control and Prevention, more than 43 million women in the U.S. are at risk of unintended pregnancy. Women with unintended pregnancies are less likely to receive proper prenatal care; are more likely to have premature and low-birth-weight infants; and have increased physical and mental health risks, CDC said.
Third quarter of 2019
Recently, the Population Council announced a license agreement with TherapeuticsMD, a healthcare company focused exclusively on women’s health, to make Annovera available to women in the U.S.
Through the license agreement, TherapeuticsMD will provide 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.
Proceeds from the license agreement will be reinvested into the Population Council’s research and development programs.
How it works
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 trace potential problems.