U.S. Food and Drug Administration (FDA) has approved Fycompa (perampanel) tablets by Eisai Inc. for the treatment of partial onset seizures in patients of epilepsy of and above age 12. FDA has taken the decision after three successful clinical trials of Fycompa on seizure control.
Partial seizures are the most common type of seizure in patients of epilepsy, which is a brain disorder with abnormal or excessive neuronal activity. Seizures are usually characterized by the presence of repetitive limb activities (spasms), unusual actions, and generalized convulsions with loss of consciousness.
“Some people with epilepsy do not achieve satisfactory seizure control from treatments they are currently using,” said Russell Katz, M.D., director of the Division of
Neurology Products in the FDA’s Center for Drug Evaluation and Research. “It is important to have a variety of treatment options available for patients with epilepsy.”
“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,” said Lonnel Coats, President and Chief Executive Officer, Eisai Inc. “As a non-competitive AMPA glutamate receptor antagonist, FYCOMPA offers doctors and their patients a new approach towards seizure control.”
Among the most common adverse effects are dizziness, fatigue, falls, upper respiratory tract infections, weight loss, vertigo and balance disorder. Fycompa’s label shows the warning of possible serious neuropsychiatric events, so the caregivers and patients must have to alert the physician, if the patient shows changes in mood or behaviour usually not present in him or her.