Depomed’s shares fall on study results of Serada for menopausal hot flashes

Depomed reported results Monday showing that its investigational drug Serada (gabapentin GR) failed to meet several co-primary endpoints in two late-stage trials investigating the agent as a treatment for menopausal hot flashes. The company’s shares fell as much as 37 percent on the news.

The BREEZE 1 and 2 studies enrolled a combined total of 1100 women who were randomised to receive one of two doses of Serada or placebo. Both trials were designed to measure a statistically significant reduction in the frequency and severity of menopausal hot flashes for patients receiving Serada relative to placebo after four weeks and 12 weeks. Depomed said that after four weeks, the higher dose of Serada met all four co-primary endpoints, while the lower dose achieved three out of four primary goals. However, after 12 weeks, the company noted that only “one endpoint was positive” for both the higher and lower doses, with the other three not achieving statistical significance.

Michael Sweeney, Depomed's vice president of R&D, said that “while the drug effect in the studies was what we expected to see, there was an unexpectedly high placebo effect, particularly in the latter part of one of the studies.” The company’s CEO Carl Pelzel remarked that Depomed will meet “with the FDA later this quarter to discuss these results, the path to approval and any additional clinical work that may be required."

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