INDIA – Sun Pharma has launched its phenobarbital sodium injection for the treatment of neonatal seizures, SEZABY, in the United States (US).
The Mumbai-based multinational pharmaceutical company has expanded its portfolio of specialty branded products in the U.S. with the launch of SEZABY.
In a press release, Sun Pharma announced: “SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection.”
The drug major said that SEZABY for injection would be supplied as a sterile white to off-white, lyophilized powder in single-dose clear glass vials containing 100 mg of phenobarbital sodium.
Sun Pharma confirmed that its promising new drug was granted orphan drug designation by the U.S. Food and Drug Administration (US FDA) for the treatment of neonatal seizures.
The Indian pharmaceutical giant warned that users could suffer from dependence and withdrawal reactions after the use of SEZABY for a longer duration than recommended.
“Although SEZABY is indicated only for short-term use, if used for a longer duration than recommended, abrupt discontinuation or rapid dosage reduction may precipitate acute withdrawal reactions, which can be life-threatening,” the company cautioned.
Sun Pharma advised medical experts that patients receiving SEZABY for a longer duration than recommended, to reduce the risk of withdrawal reactions, could use a gradual taper to discontinue the injectable drug product.
“SEZABY is not approved for use in adolescents or adults. The unapproved use of SEZABY in adolescents and adults exposes them to risks of abuse, misuse, and addiction, which can lead to overdose or death,” the pharma giant stressed.
The injectable drug product 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.
Seizures are more common in the neonatal period than at any other time during life. The incidence of seizures during the first month of life is approximately 1 to 4 per thousand babies.
Their occurrence is associated with poor outcomes such as cerebral palsy, global developmental delay, and epilepsy in up to 40 to 60% of babies who suffer seizures
According to the Company’s note, clinical trials 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% vs. 25% were seizure-free in the respective groups,” the pharmaceutical company reported.
Moreover, Sun Pharma underscored that SEZABY is the first and only product approved by the US FDA for the management of neonatal seizures in term and preterm infants.
“SEZABY has the potential to make a meaningful difference in the lives of patients and their families, and we are proud to be able to provide physicians with this new treatment option,” said Abhay Gandhi, Chief Executive Officer (CEO) of Sun Pharma’s North America business.
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