Depomed plans additional Serada Phase 3 trial for treatment of menopausal hot flashes

Depomed, Inc. (NASDAQ:DEPO) announced today it has received guidance from the FDA in formal meeting minutes from a meeting held in December regarding Serada^TM, the company’s extended release gabapentin product candidate for the treatment of menopausal hot flashes. Based on guidance reflected in the meeting minutes, Depomed plans to conduct a single additional pivotal Phase 3 trial evaluating Serada for the treatment of menopausal hot flashes. The company expects to initiate the trial, which will be known as Breeze 3, by the end of April 2010 and to complete the trial by the end of the first quarter of 2011. The FDA has agreed to review the proposed Breeze 3 study protocol under the FDA’s Special Protocol Assessment (SPA) process.

“We believe Serada continues to hold the potential to be the first non-hormonal treatment to address menopausal hot flashes, a significant unmet need in women’s health”

“We believe Serada continues to hold the potential to be the first non-hormonal treatment to address menopausal hot flashes, a significant unmet need in women’s health,” 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 with the outcome of our recent meeting with the FDA. We believe the refinements made to the design of Breeze 3 will provide for a robust trial to evaluate the efficacy of Serada.”