SK Biopharmaceuticals, a South Korean pharmaceutical company, has received orphan drug designation status for carisbamate for the management of patients with infantile spasms (IS).
Carisbamate has previously been shown to have efficacy in trials for adult forms of epilepsy, such as partial onset seizures.
IS is a form of epilepsy associated with increased risk of death or mental retardation.
SK Biopharmaceuticals CEO Christopher Gallen said: "The designation of carisbamate as an Orphan Drug by the FDA facilitates our progression of this vital medication to yet another area of great unmet medical need."
SK drug development business vice president Jeongwoo Cho said: "Carisbamate is being developed to provide physicians with an additional treatment option for patients with IS for whom there are very few safe and effective treatments."
