Contraceptive Vaginal Ring; Annovera granted FDA Approval

August 13, 2018  Source: MDEdge 245


Annovera (segesterone acetate and ethinyl estradiol vaginal system), a multi-use donut-shaped ring, was recently approved and presented to the Population Council by the FDA.

The non-recyclable, elastic vaginal system is positioned in the vagina for 3 weeks and then placed 1 week out of the vagina, during which women may have a menstrual period. For 13 menstrual cycles of 28 days, this cycle is repeated.

The contraceptive ring is cleaned and kept in a container for 7 days when it is out. It can endure storage temperatures up to 30° C (86° F) and does not need refrigeration before administration.

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.

Three, open-label clinical trials involving healthy women between 18 to 40 years of age were conducted to study the efficiency and safety of Annovera. The findings revealed that nearly 2% - 4% of women may conceive during the initial year they start using Annovera.

Annovera comes with a boxed warning concerning cigarette smoking and grave cardiovascular events. Cigarette smoking in women above 35 years raises the chances of severe cardiovascular events from combination hormonal contraceptive use.

An FDA press release noted contraindications in women with an elevated risk of arterial or venous thrombotic diseases; a history of breast cancer or another estrogen- or progestin-dependent cancer; liver tumors, acute hepatitis, or severe cirrhosis; undiagnosed abnormal uterine bleeding; hypersensitivity to any of the ingredients of Annovera; and use of hepatitis C drug combinations.

The most common adverse effects of Annovera are akin to those produced by combined hormonal contraceptive products which incorporate headaches, nausea and vomiting, yeast infections, abdominal pain, dysmenorrhea, breast tenderness, irregular bleeding, diarrhea, and genital itching.

By Ddu

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