Tags: FDA | epilepsy | seizures | brain | disorders

FDA Approves New Epilepsy Drug

FDA Approves New Epilepsy Drug
(Copyright DPC)

Friday, 19 February 2016 01:26 PM


The U.S. Food and Drug Administration has approved a new anti-seizure medication for people who have epilepsy.

The drug, Briviact (brivaracetam), was approved Thursday on the basis of studies showing it reduces the frequency of seizures when used in combination with other drugs.  It is for use in people age 16 years and older who have partial onset seizures, the federal regulators said.

Epilepsy is one of the most common brain disorders. Approximately 5.1 million people in the United States have a history of epilepsy and approximately 2.9 million people in the United States have active epilepsy.

Epileptic seizure is a relatively short period of abnormal brain activity that can cause such symptoms as uncontrolled movements or spasms, abnormal thinking and behavior, muscle spasms, and/ or loss of consciousness.  A partial onset seizure occurs in a limited area of the brain.

"Patients can have different responses to the various seizure medicines that are available," said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "With the approval of Briviact, I am pleased that patients with epilepsy have a new treatment option,” he added.

Briviact was studied in three clinical trials involving 1,550 participants.  When taken along with other medications, it was shown to be effective in reducing the frequency of seizures.  The most common side included drowsiness, dizziness, fatigue, nausea and vomiting.

As is true for all drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression, and panic attacks. Rarely, patients may exhibit an allergic reaction associated with swelling of the lips, eyelids, or tongue with or without difficulty breathing, the regulatory agency noted.

Briviact is marketed by UCB, Inc. of Smyrna, Georgia.



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Federal regulators have approved a new drug aimed at reducing seizures in people who have epilepsy. It is approved for use in people age 16 and older and is to be taken in combination with other medications.
FDA, epilepsy, seizures, brain, disorders
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2016-26-19
Friday, 19 February 2016 01:26 PM
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