Lundbeck Inc. ("Lundbeck"), a wholly owned subsidiary of H. Lundbeck A/S in Denmark (LUN: Copenhagen Stock Exchange), announced today that the U.S. 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. ONFI (pronounced "ON-fee") will be available in U.S. pharmacies in early January and is a federally controlled schedule four substance (C-IV).
“ONFI will be the second therapy for challenging types of epilepsy that Lundbeck has launched in the last two and a half years.”
LGS is a rare and severe form of epilepsy that is typically diagnosed in childhood and often persists into adulthood. LGS is associated with multiple types of seizures with periods of frequent seizures, and daily seizures are common. Some of these seizures, including atonic, tonic and myoclonic seizures, may cause falls, or "drop seizures" (also referred to as "drop attacks"), which may result in injury.
"As an epileptologist treating patients with a variety of challenging seizure disorders, I'm aware of the need for new add-on therapies to address the severe and frequent seizures associated with LGS," said Joan A. Conry, MD, professor of neurology at Children's National Medical Center in Washington, D.C., and a principal investigator of the CONTAIN Trial. "Clobazam, now approved as ONFI, was shown to be effective as adjunctive therapy for reducing seizures associated with LGS, and its upcoming availability provides hope for additional seizure management to patients and their physicians, caregivers and families."
The FDA approval of ONFI was based on two multicenter controlled studies similar in terms of disease characteristics and prior treatment of patients, including a pivotal Phase III 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 II dose-ranging study was also conducted.
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 percent in the CONTAIN Trial in decreasing order of frequency included tiredness, sleepiness, lack of coordination, acting aggressive, fatigue and difficulty sleeping.
"The FDA approval of ONFI is a major milestone for Lundbeck as we continue our efforts to develop therapies for people with disorders of the central nervous system, including severe seizure disorders," said Christopher Silber, M.D., vice president of U.S. clinical research and medical affairs at Lundbeck. "ONFI will be the second therapy for challenging types of epilepsy that Lundbeck has launched in the last two and a half years."
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