Lyrica Approved as Adjunctive Tx for Partial Onset Seizures in Children

Use of Lyrica in pediatric patients with compromised renal function has not been studied
Use of Lyrica in pediatric patients with compromised renal function has not been studied

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.

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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.

It is available in 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, and 300mg capsules as well as a 20mg/mL oral solution.

For more information call (800) 438-1985 or visit Pfizer.com.