Depomed's shares drop on late-stage study results of Serada for menopausal hot flashes

Shares in Depomed fell more than 25 percent Friday after the company announced that its experimental drug Serada (extended-release gabapentin) failed to meet one of four main goals in a late-stage study of menopausal women with hot flashes.

The BREEZE 3 trial randomised 600 women to receive placebo or a total dose of 1800 milligrams of Serada dosed at 600 milligrams in the morning and 1200 milligrams in the evening. Top-line results showed that patients who took Serada had significant reductions in the severity of moderate-to-severe hot flashes at weeks four and 12 compared to placebo. In addition, while data demonstrated that the drug led to a significant reduction in the average daily frequency of hot flashes at week four versus placebo, the result was not significant at week 12.

Depomed also noted that the study failed to meet its secondary endpoints of reducing the frequency and severity of hot flashes at 24 weeks.

The company said that it will review the data, as well as previously-released results from the BREEZE 1 and 2 trials, with the FDA to "discuss possible pathways to filing" for approval. "We believe the data are sufficient to warrant discussion with the agency," CEO Jim Schoeneck commented.

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