Pfizer (PFE) Announces LYRICA Phase 3 in Pediatric Epilepsy Met Primary Endpoint

December 1, 2016 8:06 AM EST

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Pfizer Inc. (NYSE: PFE) announced positive top-line results of a study that evaluated the use of LYRICA (pregabalin) Capsules CV and Oral Solution CV as adjunctive therapy for pediatric epilepsy patients four to 16 years of age with partial onset seizures. Results showed that adjunctive treatment with LYRICA 10 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo, the primary efficacy endpoint. Treatment with LYRICA 2.5 mg/kg/day resulted in a numerical reduction in seizure frequency, which was not statistically significant. LYRICA is not approved as adjunctive therapy for pediatric epilepsy patients with partial onset seizures.

“At Pfizer we believe it is important to continue to study our medicines in relevant populations,” said Rory O’Connor, MD, Chief Medical Officer, Internal Medicine, Pfizer Inc. “Epilepsy remains a common and debilitating condition worldwide, and these results make a substantial contribution to the body of evidence for LYRICA in the pediatric population.”

The LYRICA Pediatric Epilepsy Program is composed of a total of six studies in patients with epilepsy evaluating LYRICA as adjunctive therapy, three of which have been completed and three are actively enrolling. For more information, visit www.clinicaltrials.gov.

About the Study

This Phase 3 study was a 12-week double-blind, placebo-controlled, randomized, parallel group, multi-center study including two fixed LYRICA doses. The study was conducted at 76 sites in 18 countries with 295 subjects four to 16 years of age. Subjects were randomized to placebo, LYRICA 2.5 mg/kg/day or LYRICA 10 mg/kg/day.

The safety profile observed in this study was consistent with that known for LYRICA in adults. No unexpected or new safety findings were reported in the pediatric patients with POS in this study. The most common adverse events with LYRICA 10 mg/kg/day in this study were somnolence, weight increase, increased appetite and pyrexia. The most common adverse events with LYRICA 2.5 mg/kg/day were somnolence, upper respiratory tract infection, nasopharyngitis and cough.

Complete study results are expected to be submitted for presentation at an upcoming scientific congress and for publication in a peer-reviewed medical journal.



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