Positive data from Phase III trial of Serada (Depomed Inc) to manage Menopausal hot flashes

New data shows that Serada (gabapentin GR), from Depomed Inc, may help manage Menopausal hot flashes. The BREEZE 3 study included 600 menopausal women who were treated with either Serada or placebo for 24 weeks. The trial showed that Serada significantly reduced the average frequency of hot flashes at 4 weeks (-1.69 vs. placebo) and at 12 weeks (-1.14 vs. placebo), compared with placebo.In addition, Serada significantly reduced the average severity of hot flashes at 4 weeks (-0.21 vs. placebo) and at 12 weeks (-0.19 vs. placebo). Reductions were maintained out to 24 weeks and significantly more women said their symptoms improved with Serada at 12 weeks (68% vs. 54% with placebo) and 24 weeks (74% vs. 54% with placebo). Depomed submitted an NDA for Serada to the FDA at the end of July 2012. Results were presented by JoAnn V. Pinkerton, M.D., principal investigator of BREEZE 3 and Medical Director of Midlife Health Center, Professor of Obstetrics and Gynecology at the University of Virginia, Charlottesvilleat the Annual Meeting of the North American Menopause Society.