Depomed, Inc. (Nasdaq:DEPO) announced today that it has completed enrollment of Breeze 3, the company's pivotal Phase 3 clinical trial evaluating Serada® (extended release gabapentin tablets) for the non-hormonal treatment of menopausal hot flashes.
"We are pleased to reach this important milestone in Serada's development. We continue to expect Breeze 3 will be successful based on our study design, and look forward to reporting results in the fourth quarter of this year," said Carl A. Pelzel, president and chief executive officer of Depomed.
"We appreciate the efforts of all the investigators and others who have made this possible," added Dr. Mike Sweeney, Depomed's vice president, Research and Development.
Breeze 3 Trial Design
Breeze 3 is a randomized, double-blind, placebo-controlled study of approximately 600 patients. Patients have been 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. 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.
Breeze 3 is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. An SPA is an agreement with the FDA that a proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support a product candidate's regulatory approval.