Pfizer's Lyrica (pregabalin) drug has failed to meet its primary efficacy endpoint in a Phase 3 randomised study of patients with inadequately treated painful diabetic peripheral neuropathy (pDPN).
In the Phase 3b multicentre, double-blind, randomised withdrawal efficacy and safety A0081242 trial, 665 patients received Lyrica in the single-blind phase of the study and showed an improvement in single-blind endpoint mean pain score, relative to a baseline of 2.2 points.
The study's primary endpoint was change in endpoint mean pain score relative to baseline, safety and efficacy.
The 294 Lyrica-treated patients who had =30% pain response reported a total improvement in endpoint mean pain score of 3.9 points relative to the baseline, however, the improvement was not significant compared to the placebo.
During a six-week, single-blind phase, patients who had inadequate pain control were switched to Lyrica 150mg/day or 300mg/day, while the other patients were randomised to receive a placebo or continue treatment with Lyrica for the 13-week, double-blind treatment phase.
In the US, Lyrica is approved for the management of neuropathic pain associated with diabetic peripheral neuropathy, pain after shingles, fibromyalgia and partial onset seizures in adults with epilepsy who take one or more drugs for seizures.
The Lyrica-related adverse events were peripheral edema, dizziness, somnolence and upper respiratory tract infection, dry mouth, weight gain, constipation, euphoric mood, balance disorder and increased appetite.
Pfizer's diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and other consumer products.
Image: Pfizer world headquarters. Photo courtesy of: Jim Henderson.