Positive data from Phase III trial of Serada (Depomed Inc) to manage Menopausal hot flashes - 06-Oct-2012

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.