Efficacy
Study design:
Patients from 89 investigative sites participated in this randomized, double-blind, parallel design, placebo-controlled, multicenter clinical trial. The study period included a 1-week baseline period, followed by randomization and a 2-week titration to a once-daily dose of 1800 mg G-GR or matched placebo, followed by an 8-week maintenance-dose period, followed by a 1-week dose-tapering period. Four hundred fifty-two (452) patients were randomized, with 221 receiving 1800 mg of GRALISE and 231 receiving placebo.2
Primary endpoint:
Change in baseline observation carried forward (BOCF) average daily pain score from Baseline to Week 10 of the efficacy treatment period.2
ADP=Average daily pain.
Efficacy: Secondary Endpoints
More patients reported feeling “much” or “very much” improved with GRALISE vs placebo2
Patient and Clinical Global Impression of Change (%)2
Study design:
Patients from 89 investigative sites participated in this randomized, double-blind, parallel design, placebo-controlled, multicenter clinical trial. The study period included a 1-week baseline period, followed by randomization and a 2-week titration to a once-daily dose of 1800 mg G-GR or matched placebo, followed by an 8-week maintenance-dose period, followed by a 1-week dose-tapering period. Four hundred fifty-two (452) patients were randomized, with 221 receiving 1800 mg of GRALISE and 231 receiving placebo.2
Primary endpoint:
Change in baseline observation carried forward (BOCF) average daily pain score from Baseline to Week 10 of the efficacy treatment period.2
GRALISE reduced pain by half in
approximately 30% of PHN patients.2
GRALISE reduced sleep interference compared with placebo (-2.3 vs -1.59, respectively [P=0.0001]) and this improvement persisted throughout the 10-week duration of the study. Because of the sequential hierarchical paradigm, these comparisons were not considered statistically significant.
References:
- Argoff CE, Chen C, Cowles VE. Clinical development of a once-daily gastroretentive formulation of gabapentin for treatment of postherpetic neuralgia: an overview. Expert Opin Drug Deliv. 2012;9(9):1147-1160.
- Sang CN, Sathyanarayana R, Sweeney M, et al. Gastroretentive gabapentin (G-GR) formulation reduces intensity of pain associated with postherpetic neuralgia (PHN). Clin J Pain. 2013;29(4):281-288.
- Data on file. Almatica Pharma LLC; 2009.