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FDA approves new epilepsy drug treatment

The new medicine, Briviact (generic name brivaracetam, which is the active ingredient), is described as an add-on treatment for partial onset seizures in patients. It is intended for people aged 16 years and older who suffer from epilepsy.

Epilepsy describes a group of neurological diseases characterized by epileptic seizures (two seizures are required for a person to be diagnosed as an ‘epileptic’.) Seizures vary considerably in severity (seizures are abnormal electrical activity in the brain.) The causes of the condition probably vary, and include of brain injury, stroke, brain tumors, and substance use disorders. Genetic connections are rare.

With the new drug, produced by UCB, Inc. (Smyrna, Georgia, U.S.), the aim is to deal with “partial onset seizures.” When people have simple partial seizures, they are fully awake, alert and able to interact throughout the seizure. The seizures last for about two minutes and are characterized by muscle spasms and strange sensation. Thought processes are also disrupted.

Epilepsy is hard to treat and up to one third of those with the condition are resistant to currently available treatments. For this reason, considerable research as gone into therapeutic alternatives.

The effectiveness of the new drug was demonstrated in three clinical trials, where 1,550 subjects were evaluated. The outcome was that the rate of seizures was significantly reduced. Some side-effects were noted, such as drowsiness, dizziness, fatigue, nausea and vomiting. However, the objective of cutting down seizures was consistently achieved.

The new drug comes in three formulations: film-coated tablets, oral solution, and solution for injection. The medication works by brivaracetam attaching to a protein called synaptic vesicle protein 2A. This protein is involved in the release of chemical messengers from nerve cells. Briviact functions to stabilize electrical activity in the brain and thus prevent seizures.

As well as the U.S., the medication has been approved in Europe. From the U.S. perspective, Dr. Billy Dunn, of the FDA, is quoted by the website Modern Medicine as saying: “With the approval of Briviact, I am pleased that patients with epilepsy have a new treatment option.”

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Dr. Tim Sandle is Digital Journal's Editor-at-Large for science news. Tim specializes in science, technology, environmental, business, and health journalism. He is additionally a practising microbiologist; and an author. He is also interested in history, politics and current affairs.

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