FDA approves first non-hormonal treatment for menopausal hot flashes

Hisamitsu Pharmaceutical Co

28/06/2013 20:55

June 28 (Reuters) - The U.S. Food and Drug Administration approved Noven Therapeutics LLC's drug to treat hot flashes associated with menopause - a surprise decision as an advisory committee to the regulator had voted against its approval. The drug, Brisdelle, is the first approved, non-hormonal treatment for hot flashes, the FDA said in a statement. (http://link.reuters.com/suk39t) The label for Brisdelle, generically known as paroxetine, includes a boxed warning about suicidial thoughts. Last month, the regulator rejected another non-hormonal therapy, Sefelsa, prompting its creator Depomed Inc to stop spending on the drug.  ID:nASA05F0D  In March, advisers to the FDA voted against Brisdelle and Sefelsa, saying neither drug showed enough benefits to offset the risks.  ID:nL1N0BW9KN             Hot flashes, a symptom of menopause, occur in upto 75 percent of women, according to the FDA. Hormone therapy was once a standard treatment to replace the hormones the body does not make after menopause, but its use dropped after 2002, when a large clinical trial showed the therapy increased the risk of heart disease and breast cancer. Noven, a unit of Hisamitsu Pharmaceutical Co Inc  4530.T , sells a higher dose of paroxetine as Pexeva to treat major depressive disorder, panic disorder and obsessive compulsive disorder. GlaxoSmithKline PLC  GSK.L  markets a similar drug called Paxil. (Reporting By Vrinda Manocha in Bangalore; Editing by Sreejiraj Eluvangal) ((Vrinda.Manocha@thomsonreuters.com)(within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800)(Reuters Messaging: vrinda.manocha.thomsonreuters.com@reuters.net)) Keywords: NOVEN FDA/MENOPAUSEDRUG