Eton Pharmaceuticals Submits New Drug Application to the FDA for Topiramate Oral Solution (ET-101)
- Application Submitted for the Treatment of Partial-Onset Seizures and Migraine
- Eton’s Patent-Pending Product Addresses Significant Unmet Need for a Liquid Formulation of Topiramate
- Topiramate Oral Solution is Eton’s Third Neurology Product Candidate Submitted to the FDA
“Topiramate is one of the most widely compounded oral liquids, and our product addresses the unmet need for pediatric-friendly formulations of the molecule. We look forward to working with the FDA to bring a safe, effective, FDA-approved product to patients and caregivers as quickly as possible,” said
Eton’s product is expected to be the first and only FDA-approved liquid formulation of topiramate. The company’s patent-pending liquid formulation addresses the significant unmet need for patients with dysphagia and patients that require the precision dosing that a liquid can offer. Topiramate is currently FDA-approved only in tablet and capsule form. Based on IQVIA data, the market for oral topiramate is more than
ET-101 is Eton’s third neurology-focused liquid product candidates to be submitted to the FDA. Eton expects all three of the neurology product candidates to be approved and launched in 2021.
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Source: Eton Pharmaceuticals