Depomed, Inc. (Nasdaq: DEPO) today announced that it has submitted a New Drug Application (NDA) for Serada to the United States Food and Drug Administration. Serada is Depomed's proprietary extended release formulation of gabapentin in development for the treatment of menopausal hot flashes.
"We are pleased to achieve this milestone in our Serada program. We believe that if approved Serada will offer women a non-hormonal option for the treatment of menopausal hot flashes," said Jim Schoeneck, President and CEO of Depomed.
Depomed has conducted three Phase 3 studies evaluating Serada for menopausal hot flashes. Breeze 3 was completed in 2011. Breeze 1 and Breeze 2 were completed in 2009. Additional data from the Breeze clinical program will be presented at the North American Menopause Society Annual Meeting in the fourth quarter of 2012.