Lyrica Approved as Adjunctive Tx for Partial Onset Seizures in Children
The Food and Drug Administration (FDA) has approved an expanded indication for Lyrica (pregabalin; Pfizer) to include adjunctive therapy for the treatment of partial onset seizures in patients as young as 4 years old.
The approval was based on a 12-week, double-blind, placebo-controlled study (N=295) in pediatric patients 4–<17 years of age. Compared with placebo, patients treated with Lyrica 10mg/kg/day had, on average, a 21% greater reduction in partial onset seizures (P= .0185), while those treated with Lyrica 2.5mg/kg/day had, on average, a 10.5% greater reduction (P= .2577).
In addition, the responder rate (≥50% reduction in partial onset seizure frequency), a key secondary efficacy parameter, was 40.6% for Lyrica 10mg/kg/day, 29.1% for Lyrica 2.5mg/kg/day, and 22.6% for placebo. Somnolence, weight gain, and increased appetite were found to be the most common adverse reactions associated with treatment.
Lyrica, a gabapentinoid, is also indicated for the management of: neuropathic pain associated with diabetic peripheral neuropathy; postherpetic neuralgia; fibromyalgia, and neuropathic pain associated with spinal cord injury.
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