Eton Pharmaceuticals Submits New Drug Application to the FDA for Zonisamide Oral Suspension (ET-104)

- Application Submitted for the Treatment of Partial Seizures in Epilepsy Patients

- Eton’s Patent-Pending Product Addresses Significant Unmet Need for a Liquid Formulation of Zonisamide

- Application is Eton’s Sixth Drug Application Under FDA Review

DEER PARK, Ill., July 30, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today announced it has submitted a new drug application (NDA) for zonisamide oral suspension, previously known as the company’s ET-104 product candidate, to the U.S. Food & Drug Administration (FDA) for the treatment of partial seizures in patients with epilepsy.

“We know there is strong demand for liquid zonisamide from neurologist and patients, and we look forward to working with the FDA to get the product approved and available to patients as soon as possible,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

Zonisamide is widely used as a capsule to treat partial seizures, but the molecule is not FDA approved in liquid form. Eton’s patent-pending liquid formulation addresses the significant unmet need for patients with dysphagia and patients that require the precision dosing that a liquid product offers. Based on IQVIA data, more than 150,000 prescriptions of zonisamide are written annually for the treatment of epilepsy.

ET-104 is one of Eton’s three neurology-focused liquid product candidates, along with ET-105 (lamotrigine oral suspension) and ET-101 (topiramate oral solution). The company expects all three product candidates to be approved and launched in 2021.

About Eton Pharmaceuticals

Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing, acquiring, and commercializing innovative products. Eton is primarily focused on hospital injectable and pediatric rare disease products. The company’s first commercial product, Biorphen, is the only FDA approved ready-to-use formulation of phenylephrine injection and was launched in December 2019. The company’s lead pediatric product is the orphan drug Alkindi^® Sprinkle, which is currently under review with the FDA. The company has an additional seven products under development, including five that are under review with the FDA.



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Company Contact:

David Krempa



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