The tablets, from Eisai Inc., are designed to treat partial onset seizures in patients with epilepsy ages 12 years and older.
Partial seizures are the most common type of seizure seen in people with epilepsy. Epilepsy is a brain disorder in which there is abnormal or excessive activity of nerve cells in the brain. Partial seizures affect only a limited or localized area of the brain, but can spread to other parts of the brain. Seizures cause a wide range of symptoms, including repetitive limb movements (spasms), unusual behavior, 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.'
Results from three clinical trials showed improvement in seizure control in patients taking Fycompa compared with those taking an inactive pill (placebo).
The most common adverse reactions reported by patients receiving Fycompa in clinical trials include: dizziness, drowsiness, fatigue, irritability, falls, upper respiratory tract infection, weight increase, vertigo, loss of muscle coordination (ataxia), gait disturbance, balance disorder, anxiety, blurred vision, stuttering (dysarthria), weakness (asthenia), aggression, and excessive sleep (hypersomnia).
Fycompa's label has a boxed warning to alert prescribers and patients about the risk of serious neuropsychiatric events, including irritability, aggression, anger, anxiety, paranoia, euphoric mood, agitation, and mental status changes. Some of these events were reported as serious and life-threatening. Violent thoughts or threatening behavior was also observed in a few patients. Patients and caregivers should alert a health care professional immediately if changes in mood or behavior that are not typical for the patient are observed. Health care professionals should closely monitor patients during the titration period when higher doses are used.
Fycompa will be dispensed with a patient Medication Guide that provides important instructions on its use and drug safety information.
Fycompa is manufactured by Eisai Inc. of Woodcliff Lake, N.J.
Source: Eisai Inc. via Electronic News Publishing