Phase 3 Study of Lyrica for Central Neuropathic Pain
Pfizer announced study results from its Phase 3 Lyrica Study A0081107 evaluating the use of Lyrica (pregabalin capsules) in central neuropathic pain following spinal cord injury. This study was a randomized, double-blind, placebo-controlled, parallel group, multicenter study comparing Lyrica at doses of 150–600mg/day, dosed twice daily and placebo in patients (n=220) with chronic central neuropathic pain following traumatic spinal cord injury. In total, 112 patients received Lyrica and 108 patients received placebo, in 66 investigative sites in 10 countries. The primary endpoint was the duration adjusted average change (DAAC), which is a weighted average of change in pain scores based on the duration a patient participated in the study. Initial results demonstrated that this study met its primary endpoint, and further analysis of these results will be conducted.
Lyrica is an alpha2-delta ligand and a schedule C-V controlled substance currently FDA approved for neuropathic pain associated with diabetic peripheral neuropathy, post herpetic neuralgia, adjunctive therapy in partial onset seizures, and fibromyalgia.
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