FDA approves oral treatment for partial seizures in patients aged 16 years and older

The FDA has granted approval to Azurity Pharmaceuticals Inc. for its oral adjunctive therapy to treat partial seizures in adolescents and adults aged 16 years and older with epilepsy.

According to a company release, Zonisade (zonisamide oral suspension, Azurity) was approved in a 100 mg/5 mL liquid dose for oral administration once or twice per day. The efficacy and tolerability of the drug was established through three double-blind, placebo-controlled, multicenter clinical trials.

“Zonisade is the first and only FDA-approved oral liquid formulation of zonisamide, and it offers health care providers an important new treatment option for their patients with epilepsy,” Richard Blackburn, CEO of Azurity Pharmaceuticals, said in the release. “We are excited about this approval as we continue to grow our portfolio of liquid medications that meet the individual needs of certain patients.”

An estimated 65 million people worldwide have epilepsy, and one in 26 people will develop epilepsy in the United States, the release stated.

“Delivering new treatment formulations is important to help ensure diverse epilepsy populations can access the medication for management of their epilepsy, because it offers greater flexibility and customization in dosing,” Beth Dean, CEO of CURE Epilepsy, said in the release. “The FDA approval and availability of Zonisade is a welcomed advancement for patients and their families who may be seeking a liquid formulation alternative to treat epilepsy.”