The trial drug from Depomed (DEPO), Serada, met three of four co-primary efficacy endpoints in reducing the severity and frequency of hot flashes, according to the Firm yesterday. The severity endpoints at 4 and 12 weeks were met, as well as the frequency endpoint after 4 weeks. However, the drug failed to significantly reduce the frequency of flashes at 12 weeks, and also fell short on both secondary measures of frequency and severity at 24 weeks, the full treatment duration of the study.
Trial results released yesterday came from Breeze 3, the third phase III study of Serada to treat menopausal hot flashes which the company says affects around 75% of menopausal women in the U.S. The trial enrolled 600 women and compared a twice-daily dose of Serada to placebo.
The trial data for the drug, Serada, could be a setback for Depomed's plans to get the drug quickly to market to bolster its revenue stream, a bulk of which it currently gets from its diabetes drug Glumetza.
On a conference call to discuss these trial results the company refused to provide any insight into how much the one primary and both secondary endpoints were missed. Having provided the specific p values for the endpoints that were met, the assumption must be that the misses were significant enough to raise serious doubts about whether the company will attempt to gain regulatory approval.
Depomed's share tumbled 21.34 percent today and closed at $4.94 testing its major support level for the past 12 months. The next support level is around $2.80 to $3.00 and may present a better entry point.
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