Lyrica pregabalin: Phase IIIb data

Top-line data from the double-blind, international Phase IIIb A0081242 trial in 294 patients with inadequately treated painful DPN showed that Lyrica missed the primary endpoint of improving mean pain score from baseline to week 19 vs. placebo (3.9 vs. 3.5 points, p-value not disclosed). In the single-blind portion of the trial, 665 patients received once-daily 150 or 300 mg Lyrica for 6 weeks, after which the 294 patients who had a >=30% improvement in pain score from baseline were enrolled in the double-blind portion of the trial to receive placebo or continued treatment with Lyrica for an additional 13 weeks. ...