A Phase 3 clinical trial assessing Pfizer's (NYSE:PFE) LYRICA (pregabalin) as adjunctive therapy in pediatric epilepsy patients (ages 4 - 16) with partial onset seizures met its primary endpoint of a statistically valid reduction in seizure frequency compared to placebo at the 10 mg/kg/day dose. The 2.5 mg/kg/day dose came up short, however.
The 295-subject 12-week study was conducted at 76 sites in 18 countries.
The safety profile was consistent with that observed in adult patients.
Complete results will be submitted for presentation at an upcoming scientific conference and for publication.
LYRICA is currently approved for the treatment of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy in adults with partial onset seizures and neuropathic pain associated with spinal cord injury.
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