Pfizer has reported positive top-line results from a Phase lll trial evaluating Lyrica (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in paediatric epilepsy patients.
The double-blind, placebo-controlled, randomised, parallel group, multi-centre study featured a 14-day double-blind adjunctive treatment period.
Altogether, 175 paediatric patients aged one month to less than four years and with partial onset seizures who were not adequately controlled with one to three concomitant antiepileptic drugs were enrolled from 52 centres in 22 countries.
During the trial, patients were randomised to receive placebo, or one of two fixed doses of Lyrica three times daily in a 2:1:2 ratio.
Findings of the trials showed that adjunctive treatment with a daily dose of 14mg/kg of Lyrica resulted in a statistically significant reduction in seizure frequency versus placebo, which was the trial’s primary efficacy endpoint.
Results have also revealed that treatment with a 7mg/kg daily dose of Lyrica did not cause a statistically significant reduction in seizure frequency versus placebo.
The trial did not report any unexpected or new safety findings in paediatric patients with partial onset seizures in this study.
Pfizer Internal Medicine chief development officer James Rusnak said: “The Phase lll top-line results reinforce the efficacy and safety profile of Lyrica for paediatric epilepsy patients.
“These findings add to the data available for Lyrica in the paediatric 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, but is not approved as adjunctive therapy for partial onset seizures in paediatric epilepsy patients between one month to less than four years of age.
Epilepsy, a chronic disorder characterised by regular, unprovoked seizures, is estimated to affect more than three million people in the US, including 470,000 children.