UPDATE 1-FDA advisers vote to reject approval of Depomed's menopause drug

(Updates with details) March 4 (Reuters) - Advisers to the U.S. Food and Drug Administration on Monday recommended the agency reject a drug made by Depomed Inc to reduce the frequency and severity of hot flashes associated with menopause. The panel of advisers voted 13-1 that company failed to prove convincingly that the drug worked. They voted 12-2 that its efficacy, when balanced against risk, did not warrant approval. The drug, Sefelsa, is a long-acting version of the epilepsy drug gabapentin. A short-acting version of gabapentin made by Pfizer Inc and marketed as Neurontin was approved in 1993. Clinical trials of Depomed's drug showed it only partially reduced the frequency and severity of hot flashes while side effects included dizziness, sleepiness, headache and nausea. Gabapentin has also been shown to increase the risk of suicide. The FDA does not have to follow the recommendations of its advisory panels but it generally does. Sefelsa is one of two drugs designed to reduce hot flashes being considered on Monday. The second is a drug from a unit of Hisamitsu Pharmaceutical Co Inc that comprises a low dose version of the antidepressant paroxetine. Depomed's drug was approved in the United States in 2011 to treat shingles-related pain and is marketed under the brand Gralise. Depomed's shares were halted pending the panel's vote at $6.52 on Nasdaq.

(Reporting By Toni Clarke; Editing by Gerald E. McCormick and Sofina Mirza-Reid)

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U.S. FDA panel votes against approval of Noven's menopause drug

March 4 (Reuters) - A panel of advisors to the U.S. Food and Drug Administration recommended that the agency reject a drug for hot flashes associated with menopause made by Hisamitsu Pharmaceutical Co Inc's subsidiary Noven Pharmaceuticals Inc.

The panel voted 10-4 against approval, with the majority saying the drug's benefit was not sufficient to offset its risks. The panel was evenly divided over whether the drug was in any way effective.

(Reporting By Toni Clarke. Editing by Andre Grenon)

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

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

Keywords: MENOPAUSE/NOVEN

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FDA advisers vote against approval for Depomed's menopause drug

March 4 (Reuters) - Advisers to the U.S. Food and Drug Administration on Monday recommended the agency reject a drug made by Depomed Inc to reduce the frequency and severity of hot flashes associated with menopause.

The panel of advisers voted 12-2 against the drug, Sefelsa, which is a long-acting version of the epilepsy drug gabapentin. The panel concluded that the drug's modest efficacy did not outweigh the side effects.

(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: MENOPAUSE DEPOMED/

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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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