Pfizer announced results from a post-marketing study evaluating the safety and efficacy of Lyrica (pregabalin) capsules in adolescents aged 12–17 years with fibromyalgia. Lyrica is an alpha2-delta ligand currently approved for fibromyalgia, neuropathic pain associated with diabetic peripheral neuropathy (DPN) or spinal cord injury, postherpetic neuralgia (PHN), and as adjunct in partial-onset seizures.
The Phase 4, 15-week, double-blind, randomized , placebo-controlled study (n=107) is the first large pharmacological treatment study to be conducted in this population. The study drug was given twice daily at an initial dose of 75mg/day. Over a three-week period, the dose was optimized to 75mg/day, 150mg/day, 300mg/day or 450mg/day and maintained for 12 weeks based on tolerability and response.
The primary endpoint was not achieved as there was not a statistically significant difference in mean pain score between Lyrica and placebo (treatment difference 0.66 points; P=0.121). With the exception of mild nausea, the safety profile from this study was comparable with previous fibromyalgia studies.
Full study results are expected to be submitted for publication upon completion of analyses.
For more information call (800) 505-4426 or visit Lyrica.com.