Jim Schoeneck, President and CEO of Depomed, noted, "The BREEZE 3 study builds on the positive trends we saw in the earlier BREEZE 1 and 2 trials. We believe Serada has the potential to be the first non-hormonal and non-antidepressant therapy for hot flashes."
Depomed submitted an NDA for Serada to the FDA at the end of July 2012.
Phase 3 Trial ResultsThe first abstract reports the final results of BREEZE 3 using the supportive ANCOVA parametric analysis, which 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=0.10). The results were not statistically significant at 24 weeks for the reduction of hot flash frequency (p=0.2351) or severity (p=0.1510).Overall, Serada was well tolerated. Five percent more patients on Serada than placebo withdrew from the trial due to adverse events (16.7% vs. 11.5%, respectively). The most common adverse events were headache (9% vs. 8% placebo), daytime sleepiness, or somnolence (6% vs. 3% placebo), upper respiratory tract infections (6% vs. 4% placebo), and dizziness (13% vs. 3% placebo), which are the most bothersome side effects commonly associated with gabapentin. Of note, both treatment arms reported minimal changes in weight over the 24-week arm.