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Low-dose paroxetine OK'd for moderate hot flashes.

The Food and Drug Administration has approved paroxetine for moderate to severe hot flashes, but in a dose lower than paroxetine formulations indicated for depression, obsessive-compulsive disorder, and other psychiatric disorders.

"There are a significant number of women who suffer from hot flashes associated with menopause and who cannot or do not want to use hormonal treatments. Today's approval provides women with the first FDA-approved, nonhormonal therapeutic option to help ease the hot flashes that are so common in menopause," Dr. Hylton V. Joffe, director of the Division of Bone, Reproductive and Urologic Products in the agency's Center for Drug Evaluation and Research, said in a statement. All other approved treatments contain estrogen or estrogen plus a progestin.

The drug, called Brisdelle, is to be taken in a 7.5-mg dose once daily at bedtime. Approval came after two randomized, double-blind, placebo-controlled studies in 1,175 postmenopausal women with at least seven to eight hot flashes per day, or 50-60 per week. Treatment lasted 12 weeks in one study and 24 weeks in the other. At week 4 in the 24-week study, treated women had 28.9 fewer hot flashes per week, vs. 19 fewer on placebo; at week 12, they had 37.2 fewer, vs. 27.6 fewer on placebo. Differences persisted at 24 weeks and were statistically significant.

Brisdelle and Pexeva are marketed by Noven Therapeutics. GlaxoSmithKline markets Paxil.
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Title Annotation:NEWS FROM THE FDA
Author:Otto, M. Alexander
Publication:Clinical Psychiatry News
Date:Oct 1, 2013
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