FDA Approves Fycompa for Epilepsy Patients

The addition of Fycompa (perampanel) to the approved list of epilepsy drugs will broaden treatment options for patients.

The FDA has approved Fycompa (perampanel) to treat partial-onset seizures in epilepsy patients aged 12 years and older. The approval, announced on October 22, 2012, was based on the results of 3 clinical trials that showed that patients experienced improved seizure control while taking the medication. Approximately 60% of epileptic patients experience partial seizures, making them the most common seizure type. Perampanel was approved as adjunctive treatment; it is administered once daily in doses of 2 mg to 12 mg.

Currently, 25% to 30% of epilepsy patients are resistant to or uncontrolled with currently available drug treatments, and adding perampanel to the approved list of epilepsy drugs will broaden treatment options for patients. Perampanel targets the AMPA glutamate receptors, which are located throughout the nervous system, effectively increasing signal speed between nerve cells. This is a new mode of action, distinct from all currently available drugs.

AMPA glutamate receptors increase neuronal excitability. Agents that target and antagonize these receptors can decrease seizure activity. One previous agent in this category went through clinical trials, but the innovator stopped clinical development when drowsiness emerged as a concern.

According to the FDA, common adverse reactions experienced by patients in perampanel’s clinical trials included dizziness, drowsiness, fatigue, irritability, falls, and upper respiratory tract infection. A comprehensive list of adverse reactions can be found here.

Patients using perampanel should be made aware of the risk of serious neuropsychiatric events, such as irritability, agitation, aggression, euphoric mood, anger, paranoia, anxiety, and altered mental status. During the trials, some of these events were life threatening. A boxed warning is included with perampanel to alert patients and prescribers of these risks. The FDA advises health care professionals to observe patients closely during the titration period when higher doses are used. Additionally, patients must be reminded never to abruptly discontinue this medication.

Ms. Wick is a visiting professor at the University of Connecticut School of Pharmacy and a freelance writer from Virginia.