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SK Biopharmaceuticals' carisbamate granted orphan drug status for treating infantile spasms

Friday, April 20 2012 | Comments
Evidence Grade 0 What's This?
SK Biopharmaceuticals Co. Ltd.'s carisbamate, a chlorophenyl carbamate, received an orphan drug designation from the Food and Drug Administration for the management of infantile spasms, a form of epilepsy that is associated with increased risk for death or mental retardation.

Carisbamate, one of the key products in the firm's central nervous system development pipeline, has demonstrated efficacy in clinical trials for adult forms of epilepsy, such as partial-onset seizures, according to SK Biopharmaceuticals. The company said the exact mechanism of action of the drug's therapeutic benefit has not yet been defined.

SK Biopharmaceuticals noted that the onset of infantile spasms generally occurs during the first year of life and they usually stop by the time the child reaches 5 years of age but may be replaced by other types of seizures. Infantile spasms are the major cause of cognitive deterioration in the first year of life, the firm added.

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