FDA Approved ZONISADE™ (Zonisamide Oral Suspension) of AZURITY PHARMACEUTICALS, INC.

Summary :

• The first and only FDA-approved zonisamide oral liquid formulation
• 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.

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 ZONISADE™ (zonisamide oral suspension),

“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.”

About ZONISADE™ (Zonisamide Oral Suspension)

• API-Zonisamide Oral Suspension
• Description :Zonisamide is a sulfonamide anticonvulsant approved for use as an adjunctive therapy in adults with partial-onset seizures. Zonisamide may be a carbonic anhydrase inhibitor although this is not one of the primary mechanisms of action. Zonisamide may act by blocking repetitive firing of voltage-gated sodium channels leading to a reduction of T-type calcium channel currents, or by binding allosterically to GABA receptors. This latter action may inhibit the uptake of the inhibitory neurotransmitter GABA while enhancing the uptake of the excitatory neurotransmitter glutamate.

• Class- Antidementias; Antiepileptic drugs; Antiparkinsonians; Benzoxazoles; Small molecules; Sulfonamides
• Mechanism of Action –Antioxidants; Calcium channel antagonists; Sodium channel antagonists

• Orphan Drug Status –No
• Indication -For use as adjunctive treatment of partial seizures in adults with epilepsy.
• Protein binding -40% (at concentrations of 1.0-7.0 µg/mL)
• Half-life– 63 hours

An estimated 65 million people have epilepsy globally, and 1 in 26 people will develop epilepsy in the United States. 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.

“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.”

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.

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