Pfizer Inc. (NYSE: PFE) announced on 5/17/18 positive top-line results of a Phase 3 study examining the use of Lyrica (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age. Results showed that adjunctive treatment with Lyrica 14 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo, the primary efficacy endpoint. Treatment with Lyrica at the lower dose (7 mg/kg/day) did not result in a statistically significant reduction in seizure frequency versus placebo. The study was a post-marketing requirement by the U.S. Food and Drug Administration (FDA). Lyrica is not approved as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age.

“The Phase 3 top-line results reinforce the efficacy and safety profile of LYRICA for pediatric epilepsy patients,” said James M. Rusnak, M.D., Ph.D., Chief Development Officer, Internal Medicine, Pfizer Inc. “These findings add to the data available for LYRICA in the pediatric patient population for a complex and difficult-to-treat condition.”

Lyrica is currently approved for various indications in more than 130 countries and regions globally.
In the U.S., Lyrica is indicated to treat fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles in adults.
Lyrica is approved as adjunctive therapy for the treatment of partial onset seizures in patients four years of age and older.