Zonegran licensed as monotherapy in epilepsy

Zonegran (zonisamide) has been approved for use as monotherapy for partial seizures with or without secondary generalisation in newly diagnosed epilepsy.

Zonisamide monotherapy is non-inferior to prolonged-release carbamazepine in the treatment of newly diagnosed partial seizures | SCIENCE PHOTO LIBRARY
Zonisamide monotherapy is non-inferior to prolonged-release carbamazepine in the treatment of newly diagnosed partial seizures | SCIENCE PHOTO LIBRARY

A phase 3 double-blind, randomised non-inferiority study compared once-daily zonisamide to twice-daily prolonged-release carbamazepine as monotherapy in 583 adults with newly diagnosed partial seizures, with or without secondary generalised tonic-clonic seizures. Treatment was given for up to 24 months.

Non-inferior to carbamazepine

Results showed that 79.4% of patients receiving zonisamide in the per-protocol population remained free of seizures for six months, compared with 83.7% in the carbamazepine group (adjusted absolute treatment difference, –4.5%, 95% CI –12.2% to 3.1%), meeting the criteria for non-inferiority.

Similar safety profile

Similar incidences of treatment-emergent adverse events, including serious events and events leading to withdrawal, were observed in the two arms.

Zonegran is already licensed for use as adjunctive therapy.

View Zonegran drug record

Further information: Eisai


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