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."
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