The FDA has approved Onfi (clobazam tablets; Lundbeck) as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS) in patients ≥2 years of age. The approval of Onfi was based on data from two multicenter controlled studies similar in terms of disease characteristics and prior treatment of patients, including a pivotal Phase 3 study in 238 patients with a current or prior diagnosis of LGS. Named the CONTAIN Trial, the study’s primary endpoint was the percent reduction in the weekly frequency of drop seizures (atonic, tonic, or myoclonic), from the 4-week baseline period to the 12-week maintenance period. A Phase 2 dose-ranging study was also conducted in 68 patients that was consistent with results of the CONTAIN Trial.
Onfi, a schedule C-IV substance, is a 1,5 benzodiazepine oral antiepileptic. It will be available early January 2012 in 5mg, 10mg, and 20mg dosage strengths.
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