FDA clears Briviact for partial-onset seizures
The FDA has approved Briviact for use as an adjunct therapy to other medications for the treatment of partial-onset seizures in patients aged 16 years and older with epilepsy, according to a press release.
Briviact (brivaracetam, UCB Inc.) is an analog of levetiracetam, but has been found to have a greater potency. It was approved in Europe in January.
“Patients can have different responses to the various seizure medicines that are available,” Billy Dunn, MD, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in the release. “With the approval of Briviact, I am pleased that patients with epilepsy have a new treatment option.”
As detailed in the release, Briviact demonstrated efficacy in reducing seizure frequency in three clinical trials that involved 1,550 participants. Patients most commonly reported dizziness, drowsiness, nausea, fatigue and vomiting as adverse effects.
Patients rarely presented with an allergic reaction to the medication, which included symptoms such as swollen lips, eyelids or tongue and a possibility of difficulty breathing.
The FDA specified that Briviact must be dispensed to patients with a guide that details both use and risks, which include the risk for behavioral issues such as suicide and new or worsening depression that comes with all epilepsy drugs.
UCB’s new epilepsy drug BRIVIACT receives EU approval; 2016. Accessed February 19, 2016.