The Food and Drug Administration (FDA) has expanded the approval of Lyrica (pregabalin; Pfizer) for pediatric patients 1 month of age and older as adjunctive therapy for the treatment of partial-onset seizures. Previously, the product was approved for children ≥4 years old.
The approval was based on data from a 14-day double-blind, placebo-controlled study (N=140) in which patients as young as 3 months old were treated with either Lyrica 7mg/kg/day or 14mg/kg/day (use in patients younger than 3 months was supported by additional pharmacokinetic analyses). The primary endpoint was the 24-hour partial-onset seizure rate based on the comparison of the baseline video electroencephalogram (EEG) to a repeat 48-72 hour video EEG performed at the end of 14 days of double-blind treatment.
Results of the study showed that compared with placebo, patients treated with Lyrica 14mg/kg/day had, on average, a 43.9% greater reduction in partial-onset seizures (P=.0223); patients treated with the 7mg/kg/day dose did not show improvement relative to placebo.
In addition, a numerical improvement in responder rates (≥50% reduction in partial-onset seizure frequency) was noted in the Lyrica 14mg/kg/day group compared with placebo (53.6% vs 41.5%, respectively). Regarding safety, the most common adverse reactions associated with treatment were somnolence, pneumonia, and viral infection.
In pediatric patients, the recommended dosing regimen is dependent upon body weight (≥30kg vs <30kg). Lyrica is available in a 20mg/mL oral solution formulation in addition to the capsule form (25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, and 300mg strengths).
For more information visit lyrica.com.