United States-based Pfizer has revealed positive top-line results from a phase three study that evaluated the use of Lyrica (pregabalin) oral solution CV as adjunctive therapy for partial onset seizures in paediatric epilepsy patients one month to less than four years of age, it was reported on Friday.

Results indicated that adjunctive treatment with LYRICA 14 mg/kg/day resulted in a statistically significant decrease in seizure frequency compared with placebo, the primary efficacy endpoint. Treatment with the product at the lower dose (seven mg/kg/day) did not result in a statistically significant reduction in seizure frequency versus placebo.

This Phase three study was a double-blind, placebo-controlled, randomised, parallel group, multi-centre study that included 14 days of double-blind adjunctive treatment. In this study, 175 paediatric patients with partial onset seizures who were not adequately controlled with one to three concomitant antiepileptic drugs were enrolled from 52 centres in 22 countries. Patients were randomized to placebo, or one of two fixed doses of LYRICA divided three times daily, LYRICA 14 mg/kg/day or LYRICA seven mg/kg/day in a 2:1:2 ratio. Complete study results are expected to be submitted for publication in a peer-reviewed medical journal. These data along with those of prior studies will be submitted to the FDA for LYRICA paediatric exclusivity determination.