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Medicines licensing

FDA approves brivaracetam for partial onset epilepsy

The US Food and Drug Administration (FDA) has approved brivaracetam (Briviact) as an add-on treatment for partial onset seizures in patients with epilepsy who are over 16 years of age.

The drug, which is indicated to treat seizures that start in a limited area of the brain, has been made available on the outcome of three clinical trials.

The trials involved 1,550 patients and confirmed that brivaracetam, when taken with other medications, was capable of reducing the number of seizures. The most common side effects included drowsiness, dizziness, fatigue, nausea and vomiting.

“Patients can have different responses to the various seizure medicines that are available,” says Billy Dunn, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research. “I am pleased that patients with epilepsy have a new treatment option.”

The FDA reiterates that a medicines guide for patients must be given when the drug is dispensed.

“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,” the FDA says. “Rarely, patients may exhibit an allergic reaction associated with swelling of the lips, eyelids, or tongue with or without difficulty breathing.”

In Europe, brivaracetam was granted a marketing authorisation for the same indication in January 2016 but is subject to additional monitoring. The drug is marketed in the UK and the United States by UCB Pharma Ltd.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20200743

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