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2022-07-19| Trials & Approvals

A New Liquid Take On an Old Epilepsy Drug Receives FDA Approval

by Reed Slater
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Azurity Pharmaceuticals Inc. announced the FDA approval of its liquid oral suspension epilepsy drug, ZONISADE, on July 18, marking the first and only approved liquid oral suspension formulation of long-time epilepsy treatment, zonisamide. The approval comes a year after Azurity purchased Eton Pharmaceuticals’ neurology portfolio.

 

Providing Alternative Administration Methods to an Established Therapy

 

An oral version of zonisamide, Zonegran, received FDA approval in 2000 as adjunctive therapy to treat partial seizures and adults with epilepsy. Over twenty years later, Azurity received approval for its liquid oral suspension version of the drug for the same indication for patients 16 and older. 

Epilepsy is a central nervous system disorder that can cause seizures or abnormal behavior. The disorder occurs in about one in 26 Americans and can present comorbidities like learning disabilities, autism, depression, and anxiety. 

There are several treatment options for those dealing with epilepsy, but new treatment options and administration methods are always welcome among the diverse population with epilepsy. 

Beth Dean, CEO of CURE Epilepsy, said, “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.” 

ZONISADE is a liquid oral suspension drug, meaning that the liquid contains solid particles dispersed throughout the liquid. The liquid formulation will provide easier access to patients who may not want to or have difficulty swallowing pills.

Related Article: Insilico Medicine Pinpoints New Targets for ALS With AI

 

Bringing Eton’s Neurology Portfolio to Market

 

Azurity’s purchase of Eton’s Neurology portfolio included three product candidates that Eton had already applied for FDA approval, lamotrigine, zonisamide, and topiramate. Since the 2021 purchase, zonisamide (ZONISADE) and topiramate (EPRONTIA) gained FDA approval while the FDA declined the approval of lamotrigine. 

Eton was set to receive up to $45 million in the sale of the drugs, $15 million upon closing, $15 million approval and product launch milestones, and $15 million upon commercial sale milestones. ZONISADE would account for a third of these profits, and Azurity will remain responsible for the commercialization of the drug while Eton will bear none of the marketing expenses. 

Azurity’s efforts to get ZONISADE FDA-approved are paying dividends for Eton, which now only has one drug left in the sale, not approved. The approval of ZONISADE appears to be a welcomed alternative to a long-time treatment with a proven track record of safety and efficacy. 

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