Efficacy: Primary Endpoint
Significant reduction in pain1,2
ADP score reduction for GRALISE was -2.1 vs -1.6 with placebo (P=0.013)2
Pain reduction as early as Week 11
Significant pain reduction vs placebo beginning Week 1 and continuing throughout 10-week study2
GRALISE vs placebo over 10 weeks2
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. 452 patients were randomized, with 221 receiving 1800 mg of GRALISE and 231 receiving placebo.
Primary endpoint: change in baseline observation carried forward (BOCF) average daily pain score from the baseline week to Week 10 of the efficacy treatment period.
ADP=average daily pain.