Eton Pharmaceuticals Inc (NASDAQ:ETON) Submits Its ET-101 New Drug Application To The FDA

Eton Pharmaceuticals Inc (NASDAQ:ETON) and its manufacturing partner, Tulex Pharmaceuticals recently announced that they are filing for a new drug application (NDA) for their pipeline drug, ET-101.

ET-101 is a topiramate oral solution that Eton and Tulex have been developing as a treatment for migraines and Partial-Onset Seizures. Eton submitted the filing to the Food & Drug Administration (FDA) and the filing highlighted three indications: Migraine prevention treatment that can be administered to individuals above 12 years old; therapy for partial-onset seizures such as seizures that are caused by Lennox-Gastaut syndrome; therapy for patients with general seizures to be administered to patients above 2 years old.

“Topiramate is one of the most widely compounded oral liquids, and our product addresses the unmet need for pediatric-friendly formulations of the molecule,” stated Eton Pharmaceuticals CEO, Sean Brynjelsen.

The CEO also added in the statement that his company looks forward to working with the FDA to deliver a safe, effective, and approved product to patients as soon as possible. If ET-101 receives NDA status from the FDA, then it will become the first topiramate liquid formulation to be given the greenlight by the regulatory authority.

Topiramate’s liquid formulation addresses the unmet needs of patients suffering from dysphagia and patients that require precision dosing such as the one that Eton can deliver through the formulation. For example, it will be ideal for children that suffer from the indicated condition as long as they are within the age recommended by physicians.

Eton finalizes its public offering

Eton also announced the closure of its public offering last week through which the company had previously announced a public offering of 3,220,000 shares of common stock. The shares were priced at $7.00 per share and it included the sale of 420,000 shares that were sold when the underwriter fully exercised its overallotment option.

Eton managed to generate $22.5 million in gross proceeds from the sale, before the offering expenses, commissions, and underwriting discounts were deducted. The company plans to use some of the net proceeds from the public offering to boost its working capital and general corporate purposes such as administration costs, capital expenditures, research, and development activities.