AZURITY PHARMACEUTICALS, INC. ANNOUNCES FDA APPROVAL OF ZONISADEtm (zonisamide oral suspension)

The first and only FDA-approved zonisamide oral liquid formulation

WOBURN, Mass., July 18, 2022 /PRNewswire/ -- Azurity Pharmaceuticals, Inc., a private pharmaceutical company focused on developing innovative products to serve the specific needs of overlooked patients, today announced the U.S. Food and Drug Administration (FDA) approval of ZONISADEtm (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.

"ZONISADEtm 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. "ZONISADEtm 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 ZONISADEtm is a welcomed advancement for patients and their families who may be seeking a liquid formulation alternative to treat epilepsy."

ZONISADEtm is the first and only zonisamide formulation for oral liquid administration to be approved by the U.S. Food and Drug Administration as an adjunctive therapy for the treatment of partial seizures in adults and pediatric patients aged 16 years and older with epilepsy. The efficacy and tolerability of zonisamide has been established in three double-blind, placebo-controlled, multicenter clinical trials. ZONISADEtm should be administered once or twice daily. Efficacy and safety of ZONISADEtm in patients below 16 years of age have not been established.  

Azurity Pharmaceuticals is a privately held pharmaceutical company that focuses on innovative products that meet the specific needs of overlooked patients. As an industry leader in providing unique, accessible and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

¹ Mehndiratta, M. M., & Wadhai, S. A. (2015). International Epilepsy Day - A day notified for global public education & awareness. The Indian journal of medical research, 141(2), 143?144.

²Epilepsy Foundation. Who can get epilepsy?. Retrieved June 15, 2022, from https://www.epilepsy.com/what-is-epilepsy/understanding-seizures/who-gets-epilepsy 

³Seidenberg, M., Pulsipher, D. T., & Hermann, B. (2009). Association of epilepsy and comorbid conditions. Future neurology, 4(5), 663?668.

SOURCE Azurity Pharmaceuticals