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Non hormonal therapy for hot flashes and night sweats
By admin at 2013-07-03 22:31
Non hormonal therapy for hot flashes and night sweats

The FDA has approved a non hormonal therapy for hot flashes, potentially providing relief for patients with ER positive breast tumors or the concenrn of such.

"Noven is proud to have developed Brisdelle™, the first and only FDA-approved nonhormonal option for the treatment of moderate to severe VMS, and to be the first company to offer both nonhormonal and hormonal treatment options for women with VMS," said Jeffrey F. Eisenberg, Noven's President and Chief Executive Officer. "We will commercialize Brisdelle™ in the U.S. through our Noven Therapeutics Women's Health division and we estimate that Brisdelle™ will be available in U.S. pharmacies in November 2013."

In clinical trial performed by Noven, Brisdelle was shown to reduce the frequency and severity of hot flashes and night sweats. Brisdelle™ was studied in one Phase 2 and two Phase 3 randomized, placebo-controlled trials in 1,276 women with VMS associated with menopause. The most common adverse reactions, defined as those experienced by at least 2 percent of patients taking Brisdelle™ compared to placebo were headache (6.3 vs. 4.8 percent), fatigue/malaise/lethargy (4.9 vs. 2.8 percent) and nausea/vomiting (4.3 vs. 2.3 percent). Of these commonly reported adverse reactions, nausea occurred primarily within the first four weeks of treatment and fatigue occurred primarily within the first week of treatment, and decreased in frequency with continued therapy. Brisdelle™ shares paroxetine warnings and precautions.



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