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.


Continue Reading

Related Articles

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.