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
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