logo
Share SHARE
FONT-SIZE Plus   Neg

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

Pfizer Inc. (PFE: Quote) 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
BlackRock (BLK) said its iShares division has launched the iShares Short Maturity Municipal Bond ETF (MEAR). The move by iShares, the world's largest manager of exchange traded funds, is part of efforts to boost its lineup of fixed income ETFs. iShares Short Maturity Municipal Bond ETF is actively... The drought crisis in California will not abate any time soon despite the onset of a somewhat weak El Nino, endangering crops and putting farmers and others to hardship. German auto giant BMW has refuted reports it is in discussion with tech giant Apple Inc. (AAPL) related to the making of an electric car. BMW has clarified that its discussion with Apple was not related to building an electric car but were "regular talks," according to a report from Reuters. On...
comments powered by Disqus
RELATED NEWS
Trade PFE now with 
Follow RTT