Mixed results for Pfizer’s two Lyrica Phase IIIb studies

Pharma giant Pfizer (NYSE: PFE) has announced mixed results from two Phase IIIb studies of Lyrica (pregabalin) capsules CV in patients with fibromyalgia (FM) and painful diabetic peripheral neuropathy (DPN).

A large number of people living with FM also suffer from depression and take antidepressant medications. The FM study, A0081275, met its primary endpoint, showing a reduction in pain associated with FM in patients who were treated concurrently with antidepressant therapy for comorbid depression. The fibromyalgia study was a multicenter, double-blind, randomized, placebo-controlled, two-way cross-over study of Lyrica. The study enrolled 197 patients diagnosed with both FM and comorbid depression who were taking a stable dose of a single antidepressant medicine for their depression for at least three months prior to the study. In each of the two double-blind treatment periods, patients were randomized to receive Lyrica (300 or 450 mg) or placebo twice per day during a six-week treatment phase, followed by a two-week washout period, and then crossed over to the opposite treatment for an additional six weeks. The study showed a statistically significant greater reduction in fibromyalgia pain in patients receiving Lyrica compared to patients receiving placebo assessed by diary-based, daily pain scores.

DPN study did not meet primary endpoint