The drug, made by Eisai Inc, the US arm of the Japanese global pharma company, is already approved for use in Iceland, Norway and the European Commission on behalf of its 27 sovereign member states.
Epilepsy is a spectrum of brain disorders, ranging from severe, life-threatening and disabling, to more benign. It arises because of abnormal or excessive activity of nerve cells in the brain, which can cause seizures that give rise to symptoms ranging from strange sensations, unusual behavior, repetitive limb movements (spasms), to generalized convulsions with loss of consciousness.
Partial seizures are the most common type of seizure, affecting some 60% of people with the condition. They affect only a limited or localized part of the brain, but can spread to other parts.
Not Enough Treatment OptionsIn about 25 to 30% of patients with epilepsy, seizures cannot be controlled with current treatment.
Russell Katz, director of the FDA's Division of Neurology Products in the agency's Center for Drug Evaluation and Research, emphasizes this point in a press statement, adding:
"It is important to have a variety of treatment options available for patients with epilepsy."
Fycompa targets the AMPA glutamate receptor, which is common throughout the central nervous system and helps speed up signals between nerve cells.
Lonnel Coats, President and Chief Executive Officer of Eisai Inc, says:
"The FDA approval of Fycompa is an important development for the treatment of patients who continue to have seizures despite being on other prescription medications for epilepsy."
"As a non-competitive AMPA glutamate receptor antagonist, Fycompa offers doctors and their patients a new approach towards seizure control."
Clinical TrialsIn approving the drug, the FDA reviewed evidence from three phase 3 multi-center, randomized, double-blind, clinical trials that showed patients taking Fycompa showed better seizure control than counterparts treated with placebo.
The most common side effects reported by patients taking Fycompa in trials included: blurred vision, stuttering (dysarthria), drowsiness, fatigue, irritability, dizziness, upper respiratory tract infection, weight increase, falls, vertigo, loss of muscle coordination (ataxia), gait disturbance, balance disorder, weakness (asthenia), aggression, excessive sleep (hypersomnia), and anxiety.
Boxed WarningThe drug's label carries a boxed warning for doctors and patients on the risk of serious neuropsychiatric events. These include: changes in mental state, agitation, aggression, anxiety, paranoia, euphoric mood, anger and irritability. Some of these changes were reported as serious and life-threatening in trials, where some patients also showed signs of violent thoughts or threatening behavior.
The FDA urges patients and carers to "alert a health care professional immediately if changes in mood or behavior that are not typical for the patient are observed," and for healthcare professionals to "closely monitor patients during the titration period when higher doses are used".
Fycompa will be dispensed with a Medication Guide that gives important instructions on how to use it safely.
The Institute of Medicine suggests there are 2.2 million people with epilepsy in the US.
Written by Catharine Paddock PhD