NON-HORMONAL TREATMENT OF HOT FLASHES
(Reuters) - US Food and Drug Administration staff said two non-hormonal drugs showed some efficacy in reducing menopausal hot flashes, and highlighted no new risks in comments issued on Thursday.
Depomed's Sefelsa (paroxetine mesylate and gabapentin) was effective in reducing the frequency and severity of hot flashes related to menopause after four weeks of treatment in studies, but results varied after 12 weeks of treatment, FDA staff observed in a report posted online on Thursday. (http://r.reuters.com/jyx36t)
They also said Japanese drugmaker Hisamitsu's paroxetine mesylate capsules was shown to be more consistent at reducing the occurrence of hot flashes than at reducing the severity of hot flashes. (http://r.reuters.com/fab46t)
Both drugs are vying to become the first approved, non-hormonal drug to treat menopausal hot flashes.
The FDA staff's comments on the marketing applications of the two drugs will be used by an advisory panel to the U.S. Food and Drug Administration, when it meets to review the drugs on Monday.
The FDA will take the panel's analysis of the drugs into account when it delivers a final decision on Sefelsa by May 31 and on Hisamitsu's paroxetine mesylate by June 28.
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