Pfizer's Epilepsy medication Lyrica gives positive results in pediatric study

Global drug giant Pfizer  recently announced  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.

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.

The company said in its press release that the study 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."

The LYRICA Pediatric Epilepsy Program is composed of a total of six studies in patients with epilepsy evaluating LYRICA as adjunctive therapy, four of which have been completed and two of which are actively enrolling. 

Epilepsy is a chronic disorder characterized by recurrent, unprovoked seizures and occurs in both adults and children. Sixty-five million people worldwide have epilepsy. In the U.S., more than three million people, including 470,000 children are living with epilepsy. Epilepsy is associated with increased morbidity and mortality and can profoundly affect multiple daily life activities. Partial onset seizures are a common seizure type in patients with epilepsy.

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