Eisai's Antiepileptic Drug Perampanel Approved in China for Adjunctive Treatment of Partial-Onset Seizures in Patients Aged 12 and Older

Source:PharmaCube Info

Author: Baihuawen

On September 30, Eisai’s perampanel tablets were approved in China for adjunctive therapy in patients aged 12 years and older with partial-onset seizures (with or without secondary generalized seizures).

Epilepsy is a common neurological disorder. According to statistics, there are approximately 50 million people with epilepsy worldwide. In China, there are about 9 million patients with epilepsy, among whom approximately 60% are affected by focal seizures, and 40% of these patients with focal seizures require adjunctive therapy. About 30% of patients with epilepsy cannot achieve seizure control with existing antiepileptic drugs.

Perampanel Structural Formula

Perampanel is a highly selective, non-competitive AMPA receptor antagonist that reduces neuronal hyperexcitability associated with seizures by targeting and inhibiting glutamate activity at postsynaptic membrane AMPA receptors. According to the NextPharma database of PharmCube, the currently approved indications for perampanel are: 1) adjunctive therapy for partial-onset seizures (with or without secondary generalization) in patients aged 12 years and older with epilepsy; 2) adjunctive therapy for primary generalized tonic-clonic seizures in patients aged 12 years and older with epilepsy.

Study 335, a randomized, double-blind, parallel-group, multicenter clinical trial, demonstrated that compared with baseline, the percent change in seizure frequency per 28 days during the treatment period was -17.3%, -29.0%, -38.0%, and -10.8% in the perampanel 4 mg, 8 mg, 12 mg, and placebo groups, respectively. Among these, the perampanel 8 mg and 12 mg groups showed statistically significant differences compared with the control group. In terms of safety, the most common adverse reactions associated with perampanel were dizziness and somnolence.