Pfizer Inc. announced top-line results of a Phase 3 study evaluating the efficacy and safety of LYRICA (pregabalin) Capsules CV in adults with chronic post-traumatic peripheral neuropathic pain. The study did not meet its primary efficacy endpoint.
LYRICA is currently approved for various indications in more than 130 countries and regions globally.
LYRICA is approved for five indications in the U.S., of which four are in the therapeutic area of pain. These indications include neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia (pain after shingles), neuropathic pain associated with spinal cord injury, fibromyalgia and partial onset seizures in adults with epilepsy who take one or more drugs for seizures.
The study was conducted as a 15-week, double-blind, placebo-controlled, parallel group study with a primary objective to evaluate the efficacy of pregabalin in the treatment of chronic post-traumatic peripheral neuropathic pain. The primary efficacy endpoint was mean pain reduction from baseline compared with placebo based on pain scores from patients’ daily pain diaries. The safety profile observed in this study was consistent with that known for pregabalin. The most common adverse events with pregabalin in this study were dizziness, somnolence, nausea and fatigue.
There is currently no treatment approved by the U.S. Food and Drug Administration for post-traumatic neuropathic pain.
