Pfizer Shows Off Significant Data From Pregabalin CR Phase 3

December 18, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

Pfizer Inc. is up in Thursday trading after it announced that a study on its blockbuster drug Lyrica showed that patients using it to treat nerve pain showed improvement over those who took a placebo, a sign it could be muscling into the lucrative shingles market.

The study was the last of three Phase 3 clinical studies of Lyrica (pregabalin) and easily the most successful. The first study for epileptic adults didn’t even meet its primary endpoint, while a second study was more effective at treating nerve pain in patients with fibromyalgia.

But the third and final study followed 796 subjects who were enrolled into the single-blind phase from 116 sites in 17 countries. Of those 51.8 percent completed the single-blind phase, had a 50 percent reduction in pain compared to baseline and were randomized into double-blind phase.

The double blind, randomized second phase found that the treatment stopped being effective for only 29 out of 208 patients taking pregabalin, compared with 63 out of 205 those in the placebo group—a metric Pfizer is touting as statistically significant.

Pfizer has marker exclusivity for Lyrica in the U.S. until 2018, a territorial share uheld by a judge in 2012 via a ruling on its patent validity. Pfizer made $4.6 billion from sales of Lyrica last year, accounting for 9 percent of Pfizer’s total revenue.

The drug is currently approved for various indications in 120 countries and regions globally. Lyrica is approved for five indications in the U.S., of which four are in the therapeutic area of pain. These indications include neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia (pain after shingles), neuropathic pain associated with spinal cord injury, fibromyalgia and partial onset seizures in adults with epilepsy who take one or more drugs for seizures.