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Phase III Data for Serada (Gabapentin) Presented at Menopause Meeting
Severity and frequency of hot flashes significantly reduced (Oct. 3)
Depomed, Inc., based in Menlo Park, Calif., announced on October 3 that it is presenting two abstracts from its phase III clinical trial, BREEZE 3, at this week's 23rd Annual Meeting of the North American Menopause Society (NAMS) in Orlando, Fla. The data show that Serada, the company’s investigational nonhormonal extended-release formulation of gabapentin, may help manage menopausal hot flashes.
The BREEZE 3 study included 600 menopausal women who were treated with either Serada 1,800 mg daily (given as one 600-mg tablet in the morning and two 600-mg tablets at night) or placebo for 24 weeks. Efficacy data from the trial were positive and statistically significant for three of the four prespecified primary endpoints of frequency and severity of hot flashes at 4 and 12 weeks. Data for the key secondary endpoints of frequency and severity at 24 weeks did not achieve statistical significance.
The first abstract will report the final results of the BREEZE 3 trial using a supportive ANCOVA parametric analysis, which found that Serada helped women manage their symptoms of hot flashes. 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).
- 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).
- The reductions in the frequency and severity of hot flashes were maintained for 24 weeks (frequency: –1.08 vs. placebo; P = 0.0174, and 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 at 24 weeks (74% vs. 54% with placebo; P < 0.0001)
The second abstract will assess the effect of Serada on two measures of sleep — the Insomnia Severity Index (ISI) score and the daily sleep interference (S/I) score. At baseline, women had an ISI score of greater than 17, indicating moderate insomnia (17.54 for Serada vs. 17.33 for placebo) and an S/I score of greater than 7, indicating moderate-to-severe sleep disturbance (7.3 for Serada vs. 7.4 for placebo).
After 12 weeks of treatment, Serada produced clinically meaningful improvements in ISI scores (–8.7 vs. –6.3 for placebo; P = 0.0044) and S/I scores (–3.6 vs. –2.8 for placebo; P = 0.0056). These reductions were maintained throughout week 24: ISI score change of –8.6 vs. –6.2 for placebo (P = 0.0056) and S/I score change of –3.9 vs. –3.0 for placebo (P = 0.0084).
BREEZE 3 is a phase III, randomized, double-blind, placebo-controlled study of approximately 600 post-menopausal women experiencing seven or more moderate-to-severe hot flashes each day. Patients were randomly assigned to receive either placebo or a total dose of 1,800 mg of Serada, dosed as 600 mg in the morning and 1,200 mg in the evening. The primary efficacy endpoints were reductions in the mean frequency of moderate-to-severe hot flashes and the average severity of hot flashes, measured after 4 and 12 weeks of stable treatment.
For more information, visit the Depomed, Inc. Web site.