News Feature | March 12, 2014

Lundbeck Announces Six-Year Antiepileptic ONFI Study Results

By Estel Grace Masangkay

Lundbeck announced that its oral antiepileptic drug ONFI (clobazam) sustained freedom from seizure in the largest and longest-running trial conducted in Lennox-Gaustat Syndrome (LGS).

Results showed that adjunctive clobazam given at stable dosages through three years of therapy in the difficult-to-treat patient population sustained seizure freedom from drop seizures associated with LGS. Patients also experienced substantial seizure improvements.

The long-term, multi-center, open-label extension study involved 267 qualified patients who had undergone one of two randomized controlled trials (Phase II dose-ranging study or a pivotal Phase III study). 70 percent of patients remained in the study through its conclusion.

Lennox-Gastaut Syndrome is a rare and severe form of epilepsy often diagnosed in childhood and typically persists into adulthood. The disease is linked with several types of seizures including atonic, tonic, and myoclonic seizures also know as ‘drop seizures’ or ‘drop attacks’. These types of seizures may cause falls which may lead to potential major injuries to patients. Daily seizures are a commonplace occurrence in patients with LGS.

ONFI is 1.5-benzodiazepine indicated for the adjunctive treatment of LGS-associated seizures in patients 2 years old and above. The drug is available in the U.S. in 10mg and 20mg tablets and as a 2.5mg/mL oral suspension. ONFI is a federally controlled schedule four substance (CIV).

Joan A. Conry, lead author of the study and professor of neurology at Children’s National Health System in Washington, D.C., said “This is the largest and longest study to date evaluating an antiepileptic drug in the Lennox-Gastaut syndrome patient population. Because of the severity of LGS, an epilepsy syndrome that begins in childhood and persists over many years into adulthood, it’s important that we have this long-term data in such a large group of both children and adults.”

The company published the study results in the online journal Epilepsia.