The Food and Drug Administration (FDA) has approved Sezaby™ (phenobarbital sodium powder for injection) for the treatment of neonatal seizures in term and preterm infants.
The approval was based on data from the randomized, double-blind, active-controlled phase 2 NEOLEV2 study (ClinicalTrials.gov Identifier: NCT01720667), which evaluated the efficacy and safety of phenobarbital as first-line treatment of neonatal seizures in patients younger than 14 days of age with gestational ages between 36 and 44 weeks.
Patients who experienced electrographically-confirmed seizures were randomly assigned to receive either intravenous phenobarbital or levetiracetam. A total of 94 patients who had neurophysiologist-confirmed seizures were included in the efficacy analysis.
Results showed a statistically significantly greater percentage of patients treated with phenobarbital had seizure termination for at least 24 hours without the need for a second drug (primary endpoint), compared with those treated with levetiracetam (73% vs 25%, respectively; P <.001).
The analysis also demonstrated that 55% of patients treated with phenobarbital had seizure termination for at least 48 hours without the need for a second drug to treat seizures, compared with 13% of levetiracetam-treated patients (P <.001). The percentage of patients with seizure termination for at least 1 hour was 85% and 43% for the phenobarbital and levetiracetam groups, respectively (nominal P <.001).
The most common adverse reactions reported with phenobarbital were abnormal respiration, sedation, feeding disorder, and hypotension.
“As the first and only product specifically indicated to treat seizures in term and preterm infants, Sezaby has the potential to make a difference in the lives of patients and their families,” said Abhay Gandhi, CEO North America, Sun Pharma.
Sezaby is supplied as 100mg of phenobarbital sodium as a lyophilized powder in a single-dose vial for intravenous infusion after reconstitution. The product is expected to be available in the fourth quarter of 2023.
- Sezaby™ (phenobarbital sodium powder for injection) approved by US FDA for the treatment of neonatal seizures. News release. Sun Pharma. November 18, 2022. Accessed November 21, 2022. https://sunpharma.com/wp-content/uploads/2022/11/Press-Release-US-FDA-approval-for-phenobarbital.pdf.
- Sezaby. Package insert. Sun Pharma; 2022. Accessed November 21, 2022. https://sezaby.com/Sezaby_PI.pdf.