Depomed ($DEPO) disappointed in its third shot at a Phase III win for its drug Serada as a treatment for menopausal hot flashes, but the Menlo Park, CA-based firm's executives have given no indication they are giving up on an FDA approval. Investors reacted harshly, causing nearly a third of the firm's share value to melt away in extended trading Thursday.
The latest Phase III of the extended-release gabapentin tablets failed to achieve one of four primary goals and "key" secondary endpoints of the study, the company said. And the drug's effects appeared to taper off about halfway through the 24-week study period. The trial fell short of meeting the primary endpoint of improving frequency of hot flashes at 12 weeks and the secondary endpoints of frequency and severity at 24 weeks, according to the company.
Nevertheless, the company wants to chat with the FDA about a way forward for the program.
"We believe the data are sufficient to warrant discussion with the agency," Jim Schoeneck, the company's president and chief executive, said in a statement. "We continue to believe Serada can offer clinical benefit as a non-hormonal treatment option for women suffering from menopausal hot flashes."
- here's the company's release
- read the Dow Jones report
- and Bloomberg's article
Editor's Note: The FDA approved XenoPort and GlaxoSmithKline's gabapentin enacarbil treatment for moderate-to-severe primary restless legs syndrome in adults in April. This story initially cited a Dow Jones Newswires article that reported incorrectly that the treatment had not been approved. That incorrect information from Dow Jones was deleted in an update of FierceBiotech's report.