logo
Share SHARE
FONT-SIZE Plus   Neg

Pfizer Halts Lyrica Phase 3 Trial In Neuropathic Pain Related To HIV Neuropathy

Pfizer Inc. (PFE) said that a Phase 3 randomized withdrawal design study for Lyrica (pregabalin) in patients with inadequately treated painful diabetic peripheral neuropathy did not meet its primary efficacy endpoint, change in endpoint mean pain score relative to baseline.

According to the company, 665 patients received Lyrica in the single-blind phase of the study and had an improvement in single-blind endpoint mean pain score relative to baseline of 2.2 points. Of the 294 patients who had =30% pain response and were randomized, Lyrica-treated patients had a total improvement in endpoint mean pain score of 3.9 points relative to baseline; however, this was not statistically significant compared to placebo. Further analyses will be conducted on these initial results.

Separately, the company said it has stopped a Phase 3 clinical trial of Lyrica in patients with neuropathic pain associated with HIV neuropathy, a form of nerve damage characterized by burning pain usually beginning in the feet. The decision follows review of a planned interim analysis of the study by the trial's external Data Monitoring Committee. There were no safety concerns raised in the E-DMC review of the interim data, the company noted.

The protocol for study A0081244 called for an interim efficacy analysis when approximately half of the planned 416 subjects had been enrolled. The interim analysis included a total of 246 subjects randomized, and the results revealed that the improvements in neuropathic pain symptoms in this study were virtually identical between the Lyrica and placebo treatments.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Volkswagen AG's all electric Microbus might be available in market by 2022. As per the plan it would be available first in California. Microsoft Corp. has unveiled a new Minecraft limited edition version of the Xbox One S console during its Gamescom press conference in Germany. The pixelated device comes with 1TB of storage. It includes a custom designed grass block console, Xbox Wireless Controller - Minecraft Creeper, Minecraft system sounds, vertical stand and transparent underside with Redstone circuit accents. HTC Corp. has cut the price of its Vive virtual reality headset by $200, bringing down the system's cost to $599. The company noted that the new entry price will make the system more accessible to the mass market across the globe. The price cut for the Vive VR headset comes after the Oculus Rift's $200 price cut recently.
comments powered by Disqus
Follow RTT