Leading the Way in Life Science Technologies

GEN Exclusives

More »

GEN News Highlights

More »
Jul 12, 2011

Eisai Plans EU Filing for Epilepsy Drug as Monotherapy Following Positive Phase III Data

  • Eisai’s European subsidiary says it plans to file for EU approval of the antiseizure drug Zonegran® (zonisamide) as monotherapy in newly diagnosed epilepsy patients, on the back of positive data from a Phase III trial. The drug is already licensed as adjunctive therapy in the treatment of partial seizures in adult epilepsy patients.

    The Phase III monotherapy study (designated E2090-E044-310) compared the efficacy and safety of once-daily zonisamide with twice-daily controlled-release carbamazepine in 582 adult patients with newly diagnosed partial epilepsy. Results confirmed the noninferiority of zonisamide in terms of the proportion of patients who were seizure-free at six months: 79.4% of zonisamide-treated patients and 83.7% of carbamazepine-treated patients. Twelve-month results were consistent with those at six months.

    Zonisamide is currently being evaluated as a treatment for children with partial onset seizure who are treated with one or two other antiepileptic drugs.



Related content

Be sure to take the GEN Poll

Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

Do you agree that ecstasy should be studied for its potential therapeutic benefits?

More »