Monday, March 7, 2011
Depomed Inc., of Menlo Park, Calif., completed enrollment in its Phase III trial, designated Breeze 3, testing Serada (extended-release gabapentin tablets) as a nonhormonal treatment of menopausal hot flashes. The study, which recruited about 600 patients, is testing 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 the co-primary endpoints. The treatment duration will be 24 weeks to address FDA requirements. Breeze 3 is being conducted under a special protocol assessment.
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