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The US Food and Drug Administration (FDA) has approved Onfi™ (clobazam) as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years and older.
The FDA approval of Onfi™ was based on two multicentre controlled studies similar in terms of disease characteristics and prior treatment of patients, including a pivotal Phase III clinical study in 238 patients with a current or prior diagnosis of LGS.
Named the CONTAIN Trial, the study’s primary endpoint was the per cent reduction in the weekly frequency drop seizures (atonic, tonic, or myoclonic) from the four-week baseline period compared to the 12-week maintenance period.
A Phase II dose-ranging study was also conducted (n=68) that was consistent with results of the CONTAIN Trial.
“We are pleased with the FDA approval of Onfi™ as it represents yet another milestone for Lundbeck in the US and for our continued efforts to develop new business opportunities for the benefit of patients as well as the company,” said Executive Vice President Anders Gersel Pedersen, Head of R&D at Lundbeck.
“Onfi™ has in the largest clinical study ever conducted in LGS patients showed very solid clinical data which was further supported by several key secondary efficacy endpoints.”
The most common adverse reactions in the CONTAIN Trial included sleepiness or tiredness, fever, drooling, acting aggressive, irritability, lack of coordination and constipation.
The adverse reactions leading to discontinuation in ≥ 1% in the CONTAIN trial in decreasing order of frequency included tiredness, sleepiness, lack of coordination, acting aggressive, fatigue and difficulty sleeping.
In conjunction with approval of the LGS indication, and as a result of the FDA’s orphan designation for Onfi™ in the treatment of LGS, the FDA has also granted Onfi™ a seven-year exclusivity period during which the FDA is prohibited from approving any other formulation for LGS unless the other formulation is demonstrated to be clinically superior to Onfi™.