Depomed is hoping that the third time proves to be the charm for Serada, its experimental drug for hot flashes. Last October the developer's stock price was pounded after it unveiled data from two late-stage trials of the therapy, which failed to hit three out of four key goals after 12 weeks of treatment. Today the biotech said that it is mounting a third Phase III trial for the drug after meeting with federal regulators.
Depomed said that Breeze 3 should launch by the end of April and wrap by the end of the first quarter of 2011. Up to 600 patients will be recruited for the trial and given either a placebo or a total daily dose of 1,800 milligrams of the drug. The co-primary efficacy endpoints in the study will be reductions in the mean frequency of moderate-to-severe hot flashes, and the average severity of hot flashes, measured after four and 12 weeks of stable treatment.
"We are pleased with the outcome of our recent meeting with the FDA," says CEO Carl Pelzel in a statement. "We believe the refinements made to the design of Breeze 3 will provide for a robust trial to evaluate the efficacy of Serada."
- check out the press release