MENLO PARK, Calif.
Oct. 3, 2012
/PRNewswire/ -- Depomed, Inc. (NASDAQ: DEPO) announced today that it is presenting two abstracts from its Phase 3 clinical trial, BREEZE 3, at this week's 23
Annual Meeting of the North American Menopause Society (NAMS) in
, FL. The data showed that Serada
, Depomed's investigational non-hormonal extended-release formulation of gabapentin, may help manage menopausal hot flashes.
"Hot flashes are a disruptive problem affecting as many as three out of four menopausal women," said
JoAnn V. Pinkerton
, M.D., principal investigator of BREEZE 3 and Medical Director of Midlife Health Center, Professor of Obstetrics and Gynecology and Vice Chair of Academic Affairs at the
University of Virginia
, Charlottesville. "At this time, hormone therapy is the only approved treatment for hot flashes, yet about 40% of symptomatic women either choose not to go on hormones or are not good candidates. The BREEZE data findings are important news for women who are looking for more choices to manage their hot flashes and the sleep issues that often accompany them."
BREEZE 3 Statistical Analyses - Non-parametric Analysis vs. ANCOVA Parametric Analysis.
The BREEZE 3 study included 600 menopausal women who were treated with either Serada 1800mg daily (given as one 600mg tablet in the morning and two 600mg tablets at night) or placebo for 24 weeks. Depomed entered into a Special Protocol Assessment with the FDA with respect to the BREEZE 3 study that specified Depomed would use a non-parametric analysis for the efficacy data from BREEZE 3, and would also perform a supportive parametric ANCOVA statistical analysis. As previously disclosed, based on the primary non-parametric analysis, efficacy data from the trial were positive and statistically significant for three of the four pre-specified primary endpoints of frequency and severity of hot flashes at four and 12 weeks. Data for the key secondary endpoints of frequency and severity at 24 weeks did not achieve statistical significance.
The results of the supportive ANCOVA parametric analysis of the BREEZE 3 data were presented at NAMS. In this analysis, Serada significantly reduced the frequency and severity of hot flashes at 4 weeks and 12 weeks compared with placebo. These reductions were maintained out to 24 weeks. In addition, an assessment of sleep measures taken at the start of the trial indicated that, on average, women had clinically meaningful improvements in insomnia and sleep disturbance.