(RTTNews) - Biopharmaceutical giant Pfizer Inc. (PFE: News ) Tuesday stated that its drug lyrica (pregabalin) met the primary endpoint of positive efficacy in reducing central neuropathic pain following spinal cord injury in a global phase 3 study. The company was announcing top-line results for the study.
Central neuropathic pain is a heterogeneous group of pain conditions initiated or caused by a primary lesion in the central nervous system. This pain often occurs following spinal cord injury.
Lyrica is currently approved in 110 countries and regions. In the U.S., lyrica capsules CV is approved to treat diabetic nerve pain, pain after shingles, fibromyalgia and partial onset seizures in adults with epilepsy who take one or more drugs for seizures. It is not approved to treat central neuropathic pain in the U.S.
According to Pfizer, the final stage lyrica study, A0081107, was a randomized, double-blind, placebo-controlled, parallel group, multi-center study, comparing pregabalin and placebo in subjects with chronic central neuropathic pain following traumatic spinal cord injury.
In the study, which was conducted in 66 investigative sites in 10 countries, pregabalin was flexibly dosed as 150-600mg/day or dosed twice daily. A total of 220 subjects were enrolled in the study.
The primary endpoint of the trial was the duration adjusted average change or DAAC, a weighted average of change in pain scores based on the duration a patient is participated in the study.