FDA staff say two non-hormonal hot flashes drugs show some efficacy

(Reuters) - Food and Drug Administration staff said experimental drugs by Depomed Inc and Hisamitsu Pharmaceutical Co Inc showed efficacy in reducing menopausal hot flashes, and highlighted no new risks in comments issued on Thursday.

Depomed's shares rose 8 percent on optimism that its drug, which failed to meet pre-defined efficacy goals in studies, may still be approved to address an estimated $1.5 billion market.

Depomed's Sefelsa 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)

Japanese drugmaker Hisamitsu's paroxetine mesylate capsules was shown to be more consistent at reducing the incidence of the condition than at reducing the severity of flashes. (http://r.reuters.com/fab46t)

Both drugs are vying to become the first approved, non-hormonal drug to treat menopausal hot flashes.

Most women going through menopause experience these flashes, a complex set of feelings that start with warmth and redness, accompanied by sweating, palpitations and anxiety that typically lasts several minutes.

About 13 million of nearly 32 million women who experience hot flashes during menopause seek treatment in the United States, according to Depomed.

The only approved and most effective treatment for the condition is traditional hormone replacement therapy, but it has shown to increase the risks of breast cancer and heart stroke.

This prompted off-label use of paroxetine mesylate and gabapentin, the chemical name of Sefelsa, which are both widely available generics and shown to be moderately effective in treating hot flashes in some studies.

Depomed already sells gabapentin as Gralise to treat shingles-related pain and the drug added about $7.6 million to the company's total sales in the October-December period. Paroxetine mesylate is sold as Paxil and Pexeva, among other trade names, to treat depression and anxiety.

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FDA staff say two non-hormonal hot flashes drugs show some efficacy