Abstract
FDA and Lundbeck Inc. on October 24 announced the approval of clobazam oral tablets as adjunctive therapy for the prevention of seizures in children 2 years of age or older who have Lennox syndrome. Lundbeck will market the drug in the United States as Onfi. The company expects the tablets to be available in early January. Clobazam, a benzodiazapene, has been classified in the United States as a Schedule IV controlled substance. A medication guide must be distributed with each filled prescription of the drug. According to the National Institute of Neurologic Disorders and Stroke, Lennox syndrome is a severe form of epilepsy characterized by frequent seizures of different types that often first occur in children under 4 years of age. Most children with the syndrome suffer from cognitive and developmental problems. In clinical trials, the addition of clobazam to study participants’ antiseizure medication regimen improved seizure control when compared to placebo. The response was dose dependent, with a significant improvement in seizure control in patients taking the highest studied dose compared to the lowest.
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