Pfizer announced that the FDA approved the use of Lyrica (pregabalin capsules) for the management of neuropathic pain associated with spinal cord injury, after receiving priority review designation for this new indication. This makes Lyrica the only FDA-approved treatment option for pain affecting spinal cord injury patients.
This approval is based on two randomized, double-blind, flexibly dosed (150–600mg/day), placebo-controlled Phase 3 trials (n=357). Patients were allowed to continue taking other pain medications, including NSAIDs, opioids and non-opioids. The population of one study consisted of traumatic spinal cord injury patients. The population of the other study consisted of traumatic spinal cord injury patients and patients who had injury to the spinal cord from non-traumatic causes (eg, removal of a benign spinal tumor or spinal cord ischemic stroke). Results showed that Lyrica significantly reduced neuropathic pain associated with spinal cord injury from baseline throughout the duration of the studies (12 weeks and 16 weeks, respectively), compared to placebo. In addition, more patients receiving Lyrica showed a 30% and 50% reduction in pain than did patients receiving placebo.
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.
For more information call (800) 438-1985 or visit www.lyrica.com.