Orphan Drug Designation for Carisbamate for Infantile Spasms

SK Biopharmaceuticals announced that the FDA has granted orphan drug designation for carisbamate for the management of patients with infantile spasms.

Carisbamate has previously been shown to have efficacy in clinical trials for adult forms of epilepsy, such as partial onset seizures.

Carisbamate is a chlorophenyl carbamate that has a distinctive chemical structure. It was initially developed to reduce the adverse effects associated with other antiseizure medications while still maintaining efficacy. The exact mechanism of action of carisbamate's therapeutic benefit has not been yet been defined.

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