The approval represents an adjunctive therapy option for pediatric patients older than age 16, as well as adults.
Azurity Pharmaceuticals has announced the FDA approval of zonisamide oral suspension 100 mg/5 mL (Zonisade) as an adjunctive therapy for the treatment of partial seizures in both adult and pediatric patients older than 16 years of age with epilepsy.1
Zonisamide oral suspension is the first and only FDA approved oral liquid formulation of the drug, “offering health care providers an important new treatment option for their patients with epilepsy,” said Azurity CEO Richard Blackburn. “We are excited about this approval as we continue to grow our portfolio of liquid medications that meet the individual needs of certain patients.”
According to the epilepsy foundation, 1 in 26 people in the United States will develop epilepsy.2
“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,” said Beth Dean, CEO of CURE Epilepsy, in a press release. “The FDA approval…is a welcome advancement for patients and their families.”
Efficacy and tolerability of this medication has been established in 3 double-blind, placebo-controlled multicenter clinical trials; efficacy and safety of this medication in patients younger than 16 years of age has not been established.
1. Azurity Pharmaceuticals, Inc. announces FDA approval of Zonisade (zonisamide oral suspension). News release. July 18, 2022. Accessed July 19, 2022. https://azurity.com/azurity-pharmaceuticals-inc-announces-fda-approval-of-zonisade-zonisamide-oral-suspension/
2. Who can get epilepsy? Epilepsy Foundation. Accessed July 19, 2022. https://www.epilepsy.com/what-is-epilepsy/understanding-seizures/who-gets-epilepsy