Depomed Reaches SPA Agreement With FDA For Phase 3 Hot Flash Trial

MENLO PARK, Calif., Aug. 11, 2010 (GLOBE NEWSWIRE) -- Depomed, Inc. (Nasdaq:DEPO) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design and analysis of Breeze 3, a Phase 3 trial evaluating Serada ^® (extended release gabapentin tablets) for menopausal hot flashes.

Depomed is initiating Breeze 3 immediately as clinical sites are all on line with more than 200 patients in the screening process already. Breeze 3 is expected to be completed by the end of the third quarter of 2011, with results to be reported in the fourth quarter.

"We believe that Breeze 3 will be successful based on the new refined trial design which is expected to accurately measure Serada's drug effect, and result in a placebo effect between 45% to 55%, as seen in other published hot flash trials," said Michael Sweeney, M.D., Depomed's vice president, Research and Development.

Carl A. Pelzel, president and chief executive officer of Depomed, added, "We are pleased to reach an SPA agreement with the FDA, and advance this important product candidate closer to commercialization."

Breeze 3 Trial Design

Breeze 3 will be a randomized, double-blind, placebo-controlled study of approximately 600 patients. Patients will be randomized into one of two treatment arms, with patients receiving either placebo or a total dose of 1800mg of Serada dosed 600mg in the morning and 1200mg in the evening. 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. As in the prior Breeze 1 trial, the treatment duration of the study will be 24 weeks, to address the FDA's view that an effective drug should also demonstrate persistence of efficacy at 24 weeks.