4.12.2010

In a rare Saturday stock market release, Lundbeck A/S reported positive pivotal Phase III Study Results for Clobazam in treating seizures associated with Lennox-Gastaut syndrome at the American Epilepsy Society meeting in San Antonio. The statistically significant results (for the majority of endpoints, including the primary endpoint, p-value was outside of the 1% confidence interval) prompted VP of regulatory affairs of the firm Timothy M. Cunniff state, that the company expects to submit an NDA for Clobazam shortly (for the indication). Patients were included if they were being treated with one to three antiepileptic drugs at stable dosages for more than 30 days before screening and had a drop in seizures per week during the 4-week baseline period. The serious adverse events were lobar pneumonia and pneumonia, occurring in both the treatment arm in placebo group. The safety profile, the selection method and issues with dependence, sedation, and tolerance to the antiepileptic effects might be among the issues on the other end of the scale considering approval decision.