SEZABY is the first and only United States Food and Drug Administration (USFDA) approved product for the treatment of neonatal seizures in term and preterm infants.
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In the period of the first 28 days of life, seizures are known to be more common in infants. The occurrence of neonatal seizures is often linked with conditions including cerebral palsy and epilepsy.
The phenobarbital sodium SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection, said Sun Pharma in a release. The drug maker said that the USFDA has given the orphan drug designation to the product for treating neonatal seizures.
The product SEZABY is supplied as a sterile white to off-white, lyophilized powder for injection, in clear glass vials of single-dose, with 100 mg of phenobarbital sodium.
Based on the results of a phase 2 study, NEOLEV2, evaluated levetiracetam against phenobarbital in the ‘first-line treatment’ of the seizures, the SEZABY product was given approval, the company said.
Sun Pharma pointed out abnormal respiration, feeding disorder, sedation, and hypotension, among the most common adverse reactions of SEZABY, with an incidence of over five percent in all the patients.
Last week, Sun Pharma announced that it entered into a deal to acquire US-based Concert Pharmaceuticals for $576 million (around Rs 4,688 crore). Concert is a late-stage biotechnology company pioneering the use of deuterium in medicinal chemistry.
Sun Pharma shares ended 0.5 percent higher on Monday at Rs 1,045.65.