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
“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
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.
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612-387-3740
Source: Eton Pharmaceuticals