FDA Approves New Pfizer Drug for Women

Mar. 30–The federal Food and Drug Administration has approved a new Pfizer drug to treat endometriosis, a painful gynecological condition that afflicts one in 10 women.

Pfizer said that the FDA approved its depo-subQ provera, which is a long-acting injectable contraception medicine that can manage the pain of endometriosis. Pfizer officials said the new drug is the first new treatment for the condition in 15 years.

The new medicine is administered through an injection four times a year, about every 12 to 14 weeks, according to Pfizer officials. Pfizer said the medication was previously approved in December 2004 for use as a contraceptive, to be injected into a patient every three months.

Endometriosis occurs when tissue in the uterus implants itself in other parts of a woman’s body, such as the ovaries or fallopian tubes. The major symptom of the condition is pelvic pain. Endometriosis also is one of the top causes of infertility, although Pfizer officials said the exact link is unknown.

The New York-based Pfizer, which has research campuses in Groton and New London, said its new medication is as effective in treating pain as a common existing treatment called Lupron Depot, but also causes fewer “hot flash” symptoms and less loss of bone density.

Dr. Ray Urbanski, Pfizer’s medical director, said that endometriosis can worsen over time if not treated. “Women will now have the opportunity to get pain relief as effective as a commonly prescribed treatment but with fewer hot flashes and less (bone loss),” he said.

a.cronin@theday.com

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