Pfizer's Lyrica misses primary endpoint in seizure frequency trial; positive in fibromyalgia

US pharma behemoth Pfizer (NYSE: PFE) revealed disappointing top-line results of a double-blind, placebo-controlled, Phase III study evaluating both the 165mg dose and 330mg dose of its blockbuster drug Lyrica (pregabalin) controlled-release (CR) formulation in adult patients with partial onset seizures with epilepsy. These indicate pregabalin CR did not meet its primary endpoint comparing the change in seizure frequency to placebo, although both doses were well-tolerated.

This clinical trial is one of three Phase III studies of the pregabalin CR formulation, which will ascertain the potential use of pregabalin as a once-a-day therapy. The other two studies are evaluating the pregabalin CR formulation in fibromyalgia and post-herpetic neuralgia. Pfizer will continue to further analyze these top-line results as well as the top-line results of the other two studies.

But improvement observed