First and only product approved for treating seizures in neonatal patients
Sun Pharma and Sun Pharma Advanced Research Company (SPARC) announced that the US Food and Drug Administration (US FDA) has approved SEZABY™ (phenobarbital sodium powder for injection) for the treatment of neonatal seizures.
As per a statement, this approval makes SEZABY the first and only product specifically indicated in the US for the treatment of neonatal seizures in term and preterm infants. SEZABY is expected to be available in the US in Q4FY23.
SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection. It was granted orphan drug designation by the US FDA for the treatment of neonatal seizures.
SEZABY was recently licensed by SPARC to Sun Pharma. Under the terms of the license agreement, SPARC is eligible to receive a milestone payment on approval of SEZABY by the US FDA.
SEZABY was approved based on the results of NEOLEV2, a phase 2 study that evaluated levetiracetam compared to phenobarbital in the first-line treatment of neonatal seizures. The randomized controlled trial compared the incidence of recurrent seizures in neonates treated with phenobarbital vs. levetiracetam in 94 neonates. Twenty-four hours following the administration of phenobarbital or levetiracetam, 73 per cent vs. 25 per cent were seizure-free in the respective groups.
The most common adverse reactions (incidence > 5 per cent patients overall) were abnormal respiration, sedation, feeding disorder, and hypotension.