Pfizer Reports Phase IIIb Lyrica Results

Pfizer’s Phase IIIb study with Lyrica (pregabalin) Capsules CV in patients with fibromyalgia (FM), A0081275, met its primary endpoint, showing a reduction in pain in patients who were treated concurrently with antidepressant therapy for comorbid depression. Separately, Phase IIIb study in diabetic peripheral neuropathy DPN pain, A0081269, did not meet its co-primary endpoints by sufficiently reducing DPN pain compared to placebo.

The fibromyalgia study (A0081275) was a multicenter, double-blind, randomized, placebo-controlled, cross-over study of Lyrica in the treatment of FM pain in patients taking antidepressant therapy for comorbid depression. The study showed a statistically significant reduction in fibromyalgia pain in patients receiving Lyrica compared to patients receiving placebo assessed by diary-based, daily pain scores. The safety profile of Lyrica was consistent with previous studies and current product labeling.