Drugs Xagena
A phase III clinical trial ( Study 332 ) of AMPA receptor antagonist Perampanel ( Fycompa ) has met its primary endpoints in patients with primary generalized tonic-clonic ( PGTC ) seizures, one of the most severe forms of generalized seizures.
The study was a double-blind, randomized, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive Perampanel therapy in 164 patients aged 12 years and older with uncontrolled PGTC seizures receiving one to a maximum of three antiepileptic drugs.
Patients were randomized to receive Perampanel or placebo in a 1:1 ratio.
The study has demonstrated that Perampanel significantly reduces PGTC seizure frequency ( primary analysis for the U.S. ) and improves responder rates ( the percentage of patients who experienced a 50% or greater reduction in PGTC seizure frequency, primary analysis for the EU ), the study's two primary outcome measures, when compared to placebo.
In this study, the most common adverse events ( greater than 10% in the Perampanel arm and greater than placebo ) were dizziness, fatigue, headache, irritability and somnolence.
The adverse event profile observed in the study was similar to that observed in other studies with Perampanel.
With epileptic seizures being primarily mediated by the neurotransmitter glutamate, Perampanel is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors.
Fycompa has been launched in the U.S., Europe and Canada as an adjunctive treatment for partial-onset seizures ( with or without secondary generalized seizures ) in patients with epilepsy aged 12 years and older.
Epilepsy reportedly affects nearly 1 million people in Japan, 2.4 million people in Europe ( G5 ), 2.2 million people in the U.S., and more than 50 million people worldwide. Epilepsy is broadly categorized by seizure type, with partial-onset seizures accounting for approximately 60% of epilepsy cases and generalized seizures accounting for approximately 40%.
Primary generalized tonic-clonic ( PGTC ) seizures are one of the most common and most severe forms of generalized seizures, accounting for approximately 60% of generalized epilepsy and approximately 20% of all epilepsy cases.
For the majority of patients, a PGTC seizure begins with a loss of consciousness without any prior warning symptoms and a sudden contraction of the tonic muscles, causing the patient to fall down ( tonic phase ). This is followed by violent convulsions ( clonic phase ) until the muscles finally relax, and the patient is left with a disturbance of consciousness.
As this is a serious event, it is seen as a major hindrance on daily life. While the seizure generally only lasts a few minutes, the patient will often feel confused, groggy or drowsy for a short period of time before returning to normal. ( Xagena )
Source: Eisai, 2014
XagenaMedicine_2014
