Eton Pharmaceuticals, Inc, a speciality pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced that in tandem with its development and manufacturing partner Tulex Pharmaceuticals, it has submitted a new drug application (NDA) for topiramate oral solution to the U.S. Food & Drug Administration (FDA). The product candidate, formerly known as ET-101, was submitted for three indications, including monotherapy for the treatment of partial-onset or primary general tonic-clonic seizures in patients two years age and older; adjunctive therapy for the treatment of partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients two years of age and older; and as a preventative treatment of migraine in patients 12 years of age and older.

“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 Sean Brynjelsen, CEO of Eton Pharmaceuticals.

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 $800 million annually.

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.