Fycompa (perampanel), the first in an entirely new class of treatment for partial onset seizures (the most common form of epilepsy), officially launched in Spain. The new therapy is indicated for the adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.
Perampanel is the only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures. This mechanism of action is different to other, currently available AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime and, significantly, is the only new-generation partial epilepsy treatment approved to treat adolescents with epilepsy from launch.
Epilepsy is one of the most common neurological conditions in the world. Around 400,000 people inSpain live with the condition.
“Almost a third of people with partial epilepsy continue to experience seizures despite the treatment options currently available,” commented Dr. José Serratosa, an Epileptologist at the Epilepsy Unit of the Fundación Jiménez Díaz University Hospital, Madrid. “New treatment options such as this are a welcome addition to doctors’ epilepsy treatment armamentarium.”
Perampanel’s reimbursement approval in Spain is based on three randomised, double-blind, placebo-controlled and dose-escalated global pivotal Phase 3 studies (304, 305, 306) and an open-label extension study (307). The three global pivotal studies show consistent results in the efficacyand tolerability of perampanel as an adjunctive therapy in people with partial onset seizures, with or without secondary generalisation.
The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia. Results from the open-label extension study also demonstrate perampanel’s efficacy and favorable tolerability profile over the longer term.
Dr. Javier Sánchez, medical manager, Eisai Spain, commented: “We’re pleased to announce the launch of perampanel in Spain. As an emerging leader in the field of epilepsy, Eisai is committed to developing innovative therapies to meet the unmet needs of people with epilepsy who need alternative treatment options to help them achieve seizure control.”
Discovered and developed by Eisai in Europe and Japan, perampanel is manufactured in the UK and was approved by the European Commission on July 23, 2012.
The launch of perampanel in Spain underscores Eisai’s human health care (hhc) mission, the company’s commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide.
Date: January 16, 2013
Filed Under: Drug Discovery