AZURITY PHARMACEUTICALS, INC. ANNOUNCES FDA APPROVAL OF ZONISADE (zonisamide oral suspension)
Azurity Pharmaceuticals, Inc., a private pharmaceutical company focused on developing innovative products to serve the specific needs of overlooked patients announced the U.S. Food and Drug Administration (FDA) approval of ZONISADE (zonisamide oral suspension),
100 mg/5 mL as adjunctive therapy for the treatment of partial seizures in adults and pediatric patients aged 16 years and older with epilepsy.
“ZONISADE™ is the first and only FDA-approved oral liquid formulation of zonisamide, and it offers healthcare providers an important new treatment option for their patients with epilepsy,” said Richard Blackburn, CEO of Azurity Pharmaceuticals. “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 have epilepsy globally, and 1 in 26 people will develop epilepsy in the United States.1,2 Epilepsy can also present comorbidities and complications such as learning disabilities, autism, anxiety, or depression, contributing to the burden on patients and their families in the management of this complex brain disorder.3
“The provider community continues to seek reliable formulations of medicines that may reduce the epilepsy patient and caregiver burden and help improve treatment adherence,” said Dr. Jim Wheless, Chair, Pediatric Neurology, University of Tennessee Health Science Center. “ZONISADE addresses an important unmet need in patients who have difficulty swallowing or who are unable or unwilling to take tablets.”
“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. “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.”