FDA Okays New Extended-Regimen Oral Contraceptive

Megan Brooks

Disclosures

April 01, 2013

The US Food and Drug Administration (FDA) has approved levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets (Quartette, Teva Pharmaceuticals) for the prevention of pregnancy.

Quartette represents the next generation of extended-regimen oral contraceptives and was designed to minimize breakthrough bleeding between scheduled periods, the company said in a statement.

Quartette is a 91-day oral regimen during which the dose of estrogen increases at 3 distinct points during the first 84 days and the amount of progestin remains consistent, followed by 7 days of 10 μg ethinyl estradiol.

"Breakthrough bleeding can be experienced with any birth control pill, especially during the first few months, and is one of the reasons a large number of women discontinue extended regimens," James A. Simon, MD, clinical professor of obstetrics and gynecology at George Washington University School of Medicine, Washington, DC, said in the manufacturer's statement.

"The estrogen in Quartette increases at specific points and provides 4 short light periods a year. Breakthrough bleeding decreases over time, which might help encourage patient adherence."

In a phase 3 clinical trial involving more than 3000 women, the regimen was 97% effective at preventing pregnancy. The most common adverse reactions (>2%) were headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, weight gain, mood changes, anxiety/panic attack, breast pain, and migraines.

Breakthrough bleeding and unscheduled spotting decreased over the course of successive 91-day cycles, the company said.

Quartette is a "uniquely differentiated product and is based on Teva's research into when breakthrough bleeding is most likely to occur with these regimens," said Jill DeSimone, senior vice president and general manager, Global Teva Women's Health.

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