Eisai has launched Fycompa (perampanel) in Norway as treatment for focal seizures with or without secondarily generalised seizures in people with epilepsy who are 12 years and older. Perampanel is a new anticonvulsant for the treatment of uncontrolled focal epilepsy, which is the most common form of this disease.
There are more than 45,000 people in Norway who have epilepsy. Finding a successful treatment of focal epilepsy, remains a significant challenge in some patients, and the incidence of uncontrolled partial epilepsy remains high, despite the many available AEDs. 20 – 40 per cent of patients with newly diagnosed epilepsy will develop refractory epilepsy.
Perampanel is the first approved antiepileptic which selectively acts on AMPA receptors, which is a protein in the brain that are instrumental when seizures caused and spread within the brain. This mechanism is different from other antiepileptic drugs that are already on the market. In addition perampanel the additional advantage that it is given as a daily dose at bedtime, and the sole of the new generation treatments of focal epilepsy is approved for treating adolescents with epilepsy from the launch.
"Physicians and patients in Norway will greet perampanel welcomed as a new option in the treatment of epilepsy with focal seizures. This can help people living with epilepsy to improve seizure control," said Dr Karl Otto neck from the Faculty of complex epilepsy - SSE at Oslo University. "Perampanel can also help to increase treatment compliance through a single daily dose, thereby providing better results for patients and decrease the burden of taking many tablets per day, which individuals with epilepsy may experience."
Efficacy and side effect profile perampanel has been demonstrated in three phase III studies were global, randomized, double-blind and placebo-controlled. These included 1480 patients with epilepsy. The studies showed consistent results of efficacy and side effects of perampanel as adjunctive therapy in people with focal seizures (with or without secondary generalization). The most frequently reported adverse events were dizziness, somnolence, fatigue, headache, fall , irritability and ataxia.
Norwegian award for perampanel was approved by the Board of Health on November 15, 2012. Perampanel got positive assessment from the CHMP in May 2012, and was approved by the EU on July 23, 2012, and received its first launch in the September 13, 2012. FDA approved a new application for approval of the new drug in March 2012, and has provided a Prescription Drug User Free Act (PDUFA - the release of prescription drugs) with October 22, 2012 as the target date.
The development of perampanel emphasizes the mission Eisai has in health care for people - Human Health Care (HHC). The company is committed to finding innovative solutions for the prevention of disease, treatment and care that provides health and well-being of people worldwide. Eisai focuses on the treatment area epilepsy, and working to meet the unmet medical needs of patients with epilepsy and their families. Eisai is proud to now be able to market several products epilepsy in Europe, the Middle East, Africa and Russia (EMEA) than any other company.
Perampanel is a highly selective, non-competitive glutamatreseptorantagonist of a AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid), which have shown a reduction in the number of relapses in studies in phase II and III. AMPA receptors, which are frequently present in almost all excitatory neurons, and transmits signals stimulated by excitatory neurotransmitter glutamate in the brain and are thought to play a role in diseases of the central nervous system have excessive nevroeksitatorisk signaling characteristics. These include epilepsy, neurodegenerative disorders, movement disorders, pain and psychiatric disorders.
Epilepsy is one of the most common neurological disease states in the world, affecting approximately eight in 1000 in Europe, and an estimated 50 million people in the world have this disorder. Epilepsy a chronic disorder of the brain that affects people of all ages. It is characterized by abnormal discharges of neuronal activity that causes seizures. The severity of the seizures can vary from short attention fracture or muscle contractions to severe and prolonged convulsions. Depending on the attack type, seizures be limited to a part of the body, or can involve the entire body. Seizures can also vary in frequency from less than one per year to several per day. Epilepsy has many possible causes, but often the cause is unknown.