Japanese drugmaker Eisai Co Ltd's Fycompa tablets get approval by the FDA to treat partial seizures in epileptic patients. The drugs in the market for the treatment have not been up to the mark.
Partial onset seizures are commonly found among people with epilepsy, aged 12 and older. Epilepsy involves abnormal activity of the nerve cells in the brain. Centers for Disease Control and Prevention have found it affects about 2 million Americans.
Dr. Russell Katz, director of the Division of Neurology Products in the Food and Drug Administration's Center for Drug Evaluation and Research, says partial seizures affect a certain portion of the brain, but eventually it may spread to different parts of the brain as well. Few symptoms of seizures are spasms, unusual behavior and loss of consciousness.
"Some people with epilepsy do not achieve satisfactory seizure control from treatments they are currently using," Katz said in a statement. "It is important to have a variety of treatment options available for patients with epilepsy."
FYCOMPA has shown great improvement in patients with partial onset seizures regardless of secondarily generalized seizures. It has reduced the frequency significantly in patients with partial seizures.
"As a non-competitive AMPA glutamate receptor antagonist, FYCOMPA offers doctors and their patients a new approach towards seizure control," said Eisai president and chief executive officer Lonnel Coats.
There were some undesirable reactions reported by the patients getting treated with FYCOMPA. The symptoms were as follows: dizziness, drowsiness, fatigue, irritability, falls, upper respiratory tract infection, weight increase, vertigo, loss of muscle coordination, gait disturbance, balance disorder, anxiety, blurred vision, stuttering, weakness, aggression and excessive sleep.
The drug will be sold along a patient Medication Guide which will give all the important information on the usage of the drug and mention the safety measures. The date will be announced when the drug will be available to patients and physicians in the U.S. after Drug Enforcement Administration (DEA) has provided the final scheduling description.
