FDA approves Shionogi's drug for painful sex in women

WASHINGTON, Feb 26 (Reuters) - U.S. health regulators said on Tuesday they have approved a drug made by Japan's Shionogi & Co to treat women experiencing pain during sexual intercourse.

The U.S. Food and Drug Administration approved the drug, Osphena, for a type of pain known as dyspareunia, which is a symptom of vulvar and vaginal atrophy due to menopause.

Dyspareunia is associated with declining levels of estrogen hormones during menopause. Osphena, known chemically as ospemifene, is a pill that acts like estrogen on vaginal tissues to make them thicker and less fragile, resulting in a reduction in pain associated with intercourse.

The drug's label includes a boxed warning, the most severe available, alerting patients to an increased risk of strokes and deep vein thrombosis. Common side effects include hot flashes, vaginal discharge, muscle spasms and excessive sweating.

(Reporting By Toni Clarke; Editing by Gerald E. McCormick)

((toni.clarke@thomsonreuters.com)(617-856-4340)(Reuters

Messaging: toni.clarke.reuters.com@reuters.net))

Keywords: SHIONOGI DRUGAPPROVAL/

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FDA OKs drug for painful sex caused by menopause

WASHINGTON -- The Food and Drug Administration on Tuesday approved the first pill-based drug for women who experience pain during sex because of menopause.

The daily pill is called Osphena, and it is designed to treat menopausal symptoms that make the vaginal tissue thinner and more fragile, causing pain during sexual intercourse. The condition, known as dyspareunia, is one of the most commonly reported health ailments among postmenopausal women, according to the FDA. Menopause occurs when the ovaries stop producing the hormone estrogen, usually around age 45 or 50.

Osphena acts like replacement estrogen and makes vaginal tissue thicker and less fragile.

The drug carries a black box warning alerting doctors and patients that Osphena can increase the risk of endometrial cancer, stroke and blood clots. The drug's prescribing guidelines recommend that it be used for the shortest amount of time possible to achieve patients' treatment goals.

Common side effects of the drug include hot flashes, vaginal discharge, muscle spasms and excessive sweating.

The FDA approved the drug based on studies involving 1,889 postmenopausal women who were randomly assigned to receive Osphena or placebo. After 12 weeks, women taking the drug had a statistically significant improvement in their symptoms.

Osphena is made by Japanese pharmaceutical company Shionogi, which has U.S. operations in Florham Park, N.J.

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