Depomed CEO Pelzel Discusses Serada’s Cold Flush and Placebo Issues
Depomed announced earlier this week that its investigational non-hormonal therapeutic option for the treatment of menopausal hot flashes, Serada (formerly known as DM-5689), failed to meet its primary efficacy endpoints in its two pivotal BREEZE clinical studies. In my opinion, this statement is somewhat misleading: it is not so much that Serada demonstrated limited efficacy in reducing the frequency and severity of hot flushes — but more that the placebo arm demonstrated higher than expected drops in daily frequency of hot flashes. Serada is an extended release formulation of generic gabapentin, an anti-seizure drug with published clinical data (going back to 2000) showing benefit in helping postmenopausal women control hot flashes. For many women, however, the trade-off has been that…
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