Lundbeck announced Monday that the FDA approved Onfi (clobazam) for the adjunctive treatment of seizures in patients with Lennox-Gastaut Syndrome (LGS) aged two years and older. The drugmaker noted that the FDA granted a seven-year exclusivity period.
Approval of the oral antiepileptic drug, which will be available in pharmacies in the US in January 2012, was based on data from two studies, including the Phase III CONTAIN trial in 238 patients with a current or prior diagnosis of LGS. Data from this study showed that high doses of Onfi when added to ongoing seizure medication, decreased weekly seizures by an average of 68 percent compared with placebo, while medium doses decreased weekly seizures by 49 percent on average. In both studies, patients taking medium or high doses of Lundbeck’s drug had improved seizure control versus placebo or low-dose Onfi.
Russell Katz, director of the FDA’s division of neurology products, commented that LGS "is a difficult condition to treat and it will be helpful to have an additional treatment option."
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