Depomed shares plummet as Ph III Serada trial fails one endpoint
Shares of US specialty drugmaker Depomed (Nasdaq: DEPO) fell 28.2% to $4.52 last Friday, after the company released top-line results from BREEZE 3, a Phase III trial evaluating the efficacy and safety of Serada (extended-release gabapentin tablets) for menopausal hot flashes, which showed the drug failed to meet one of four study endpoints.
Efficacy data from the trial were positive and statistically significant for three of the four pre-specified primary endpoints of frequency and severity at four and 12 weeks. However, data for the key secondary endpoints of frequency and severity at 24 weeks did not achieve statistical significance, the company stated. Safety results showed that Serada was well-tolerated.
Based on these results, and combined with the data from prior BREEZE 1 and 2 Phase III trials, Depomed intends to review the results with the US Food and Drug Administration and discuss possible pathways to filing a New Drug Application.
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