BioSante says hot flash gel study is positive

Drug maker BioSante Pharmaceuticals Inc. on Wednesday said its experimental drug relieved hot flashes better than a placebo, and that it will soon file with U.S. regulators for approval.

Shares rose about 6 percent on the American Stock Exchange in opening trade.

Among 484 patients followed for 12 weeks on three doses of the investigational compound, patients experienced a drop in the frequency and severity of hot flashes by week 5, and as early as week 4 with higher doses.

Side effects of the gel, to be spread along arms and shoulders, included breast tenderness and nipple pain. No serious adverse events were detected.

There was no difference in trial discontinuation or drop outs among those on the treatment compared with those on a placebo, the company said.

Shares rose 23 cents to $4.06 on the American Stock Exchange in opening trade.

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