Pfizer has announced positive results from a phase 3 study that evaluated the use of pregabalin (Lyrica) capsules CV and oral solution CV as adjunctive therapy for pediatric epilepsy patients 4 to 16 years of age with partial-onset seizures. Adjunctive treatment with pregabalin 10 mg/kg per day resulted in a statistically significant reduction in seizure frequency compared with placebo (the primary efficacy endpoint). Treatment with a lower pregabalin dosage (2.5 mg/kg per day) resulted in a numerical reduction in seizure frequency, which was not statistically significant.
The 12-week, double-blind, placebo-controlled, randomized, parallel-group study involved 295 pediatric subjects in 18 countries.
The safety profile observed in this study was consistent with that known for pregabalin in adults. The most common adverse events with pregabalin 10 mg/kg per day included somnolence, weight increase, increased appetite, and pyrexia. The most common adverse events associated with pregabalin 2.5 mg/kg per day included somnolence, upper respiratory tract infection, nasopharyngitis, and cough.
In the United States, pregabalin is indicated for the treatment of fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain, and pain after shingles in adults. The medication is also indicated for the treatment of partial-onset seizures in adults with epilepsy who take one or more drugs for seizures. Pregabalin is not approved as adjunctive therapy for pediatric epilepsy patients with partial-onset seizures.
Sixty-five million people worldwide have epilepsy. One in 26 individuals in the U.S. will develop epilepsy at some point in life. Approximately three million people in the U.S. have epilepsy; approximately 10% of them, or 300,000, are pediatric patients. Partial-onset seizures are the most common seizure type.
Source: Pfizer; December 1, 2016.