Danish drugmaker Lundbeck has got positive results in a phase 3 trial of its candidate drug clobazam in treating seizures associated with with Lennox-Gastaut syndrome, the company said.
Lennox-Gastaut syndrome (LGS) is is a rare and severe form of epilepsy that is typically diagnosed in childhood and persists into adulthood.
Lundbeck reiterated that it expected to submit a new drug application for clobazam as an adjunctive treatment for LGS to the US Food and Drug Administration by year-end.
The clinical test of efficacy and safety found that 77.6 per cent of patients who received high-dosage clobazam achieved a 50 per cent or greater reduction in the average weekly rate of seizures, Lundbeck said in a statement.
The two highest dosages of clobazam as an add-on therapy achieved the main objective of the study, which was a statistically significant reduction in the average weekly rate of seizures, compared with placebo, Lundbeck said.
The data from the study were presented at the American Epilepsy Society meeting in San Antonio, Texas, it said.
"While several medications are approved in the United States for treatment of LGS, many patients continue to have seizures due to the intractable nature of the disease," Joan Conry, professor of neurology and a principal investigator in the study, said in the statement.
Clobazam is marketed outside of the United States in more than 100 countries under various brand names, including Frisium or Urbanyl, Lundbeck said.
Reuters