Phase 3 Trial Update of Serada for Menopausal Hot Flashes
Depomed announced results from its Phase 3 clinical trial, BREEZE 3, investigating Serada for the management of menopausal hot flashes.
BREEZE 3 was a randomized, double-blind, placebo-controlled study of approximately 600 post-menopausal women experiencing ≥7 moderate-to-severe hot flashes each day. Patients were randomized into one of two treatment arms, with patients receiving either placebo or a total dose of 1800mg of Serada (dosed as 600mg in the morning and 1200mg in the evening) 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.
The final results of BREEZE 3 using the supportive ANCOVA parametric analysis found that Serada helped women manage their hot flashes symptoms. Specifically, the trial showed:
- Serada significantly reduced the average frequency of hot flashes at 4 weeks (-1.69 vs. placebo, P<0.0001) and at 12 weeks (-1.14 vs. placebo, P=0.0007), compared with placebo
- Serada significantly reduced the average severity of hot flashes at 4 weeks (-0.21 vs. placebo, P<0.0001) and at 12 weeks (-0.19 vs. placebo, P=0.0102)
- Reductions were maintained out to 24 weeks (frequency: -1.08 vs. placebo, P=0.0174; severity: -0.22 vs. placebo, P=0.0457)
- Significantly more women said their symptoms improved with Serada at 12 weeks (68% vs. 54% with placebo; P<0.0036) and 24 weeks (74% vs. 54% with placebo; P<0.0001)
Using the non-parametric statistical analysis, the trial results for the co-primary endpoints were statistically significant for the reduction in average frequency of hot flashes at 4 weeks (P=0.0003), the reduction in the average severity of hot flashes at 4 weeks (P<0.0001) and 12 weeks (P=0.0102), but were not statistically significant for the reduction in average frequency of hot flashes at 12 weeks (P=0.1). The results were not statistically significant at 24 weeks for the reduction of hot flash frequency (P=0.2351) or severity (P=0.151).
Additionally, an assessment on the impact of Serada on two measures of sleep, the Insomnia Severity Index (ISI) Score and the daily sleep interference (S/I) score, was announced. At baseline, women had an ISI Score of >17 indicating moderate insomnia (17.54, Serada and 17.33, placebo) and an S/I score of >7 indicating moderate-to-severe sleep disturbance (7.3, Serada and 7.4, placebo). After 12 weeks of treatment, Serada produced clinically meaningful improvement in ISI scores (-8.7 vs. -6.3 placebo, P=0.0044) and in S/I scores (-3.6 vs. -2.8 placebo, P=0.0056). These reductions were maintained throughout Week 24: ISI score change of -8.6 vs. -6.2 placebo, P=0.0056; and S/I score change of -3.9 vs. -3.0 placebo, P=0.0084).
Serada is a proprietary extended-release formulation of gabapentin. Scientists hypothesize that gabapentin may reduce hot flashes by regulating the flow of calcium in and out of cells, which is one mechanism for controlling body temperature.
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