(Updates with comment from company in fourth paragraph.)
Oct. 13 (Bloomberg) -- Depomed Inc., the maker of an experimental drug to treat menopausal hot flashes, declined as much as 32 percent in extended trading after saying the drug failed to meet one of four objectives in a late-stage study.
The medicine, Serada, was effective for three of the four primary endpoints evaluating the frequency and severity of hot flashes at four and 12 weeks of treatment, Menlo Park, California-based Depomed said today in a statement.
The company said it will review the results of the Phase 3 clinical trial, the last of three phases of studies generally required for U.S. marketing clearance, with the Food and Drug Administration and discuss “possible pathways” to filing a drug-approval application.
“We believe the data are sufficient to warrant discussion with the agency,” Chief Executive Officer Jim Schoeneck said in the statement. “We continue to believe Serada can offer clinical benefit as a non-hormonal treatment option for women suffering from menopausal hot flashes.”
In the trial, Serada failed to reduce the average daily frequency of hot flashes after 12 weeks, the company said. The drug met the three other goals of reducing the frequency of hot flashes after four weeks, and the severity after four and 12 weeks. The treatment failed to meet secondary goals of reducing the frequently and severity of hot flashes after 24 weeks.
Depomed’s shares dropped to as low as $4.30 in extended trading after gaining 3.6 percent to $6.28 at the close in New York.
--Editors: Andrew Pollack, Angela Zimm
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