Phase III Trial of Lyrica (Pfizer) for Neuropathic Pain with HIV halted

A Phase III clinical trial of Lyrica (pregabalin), from Pfizer, in patients with Neuropathic Pain associated with HIV neuropathy has been halted. The decision follows review of a planned interim analysis of the study by the trial�s external Data Monitoring Committee (E-DMC). There were no safety concerns raised in the E-DMC review of the interim data. 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. Lyrica is not approved in the US for the treatment of neuropathic pain associated with HIV neuropathy.