Fycompa (Perampanel Hydrate) Receives Expanded Indication for Primary Generalized Tonic-Clonic Seizures.

On June 22, 2015, the US Food and Drug Administration (FDA) approved an expanded indication for perampanel hydrate (Fycompa; Eisai), an oral antiepileptic drug. This new indication allows the use of perampanel hydrate as an adjunctive treatment for primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy aged ≥12 years.1 The FDA approval was based on new data from a phase 3 clinical trial showing a significant reduction in the frequency of PGTC seizures and freedom from seizures with perampanel hydrate versus placebo.1–3