Topiramate Oral Solution NDA Filing Accepted for 3 Indications


The agent will aim to be the first and only FDA-approved liquid formulation of topiramate, with a PDUFA date set in Q3 of 2021.

Sean Brynjelsen, MBA, MS

Eton Pharmaceuticals announced that the FDA has accepted its filing for the company’s new drug application (NDA) for topiramate oral solution (ET-101), with a scheduled Prescription Drug User Fee Act (PDUFA) date of August 6, 2021.1

The indications being applied for include monotherapy treatment of partial-onset or primary general tonic-clonic seizures in patients 2 years age and older; adjunctive therapy for treatment of partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older; and as preventative treatment of migraine in patients 12 years of age and older.

Eton submitted their NDA for topiramate in October 2020, and the agent aims to be the first and only FDA-approved liquid formulation. The liquid formulation is specifically designed to address the significant need for patients with dysphagia and patients that require the precision dosing that only a liquid medicine can offer.2

At the time, Sean Brynjelsen, chief executive officer, Eton Pharmaceuticals, said in a statement, "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.”

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Topiramate demonstrated its bioequivalence to Topamax (Janssen) under fasting condition in a study published in March. Results showed a 90% confidence interval for all pharmacodynamic parameters all within the 80% to 12% bioequivalence criteria. A separate food effect study conducted under federal conditions proved that the bioavailability of the drug is not impacted by food intake.3

Topamax was first approved to treat various forms of epilepsy in adults and children in 1996. Doctors have also prescribed the drug to treat patients 2 years or older whose seizures are associated with Lennox-Gastaut syndrome (LGS).4

The drug got its second FDA approval in 2004, as the FDA expanded its indications to include migraine prevention in patients 12 years or older. Topiramate reduces migraine frequency by calming overreactive pain-signal firing but does not have an impact on pain relief of a migraine after it starts.

ET-101 is the third product in Eton’s pediatric pipeline. ET-105, a lamotrigine oral suspension for the treatment of epilepsy and bipolar disorder, is also in development. Additionally, Eton is also still developing ET-104, which is a proprietary oral liquid formulation of an undisclosed molecule frequently used to treat a severe neurological condition.

1. Eton Pharmaceuticals announces acceptance for filing of new drug application for Topiramate oral solution. News release. Eton Pharmaceuticals. December 17, 2020. Accessed December 23, 2020.
2. Eton Pharmaceuticals submits new drug application to the FDA for topiramate oral solution (ET-101). News release. Deer Park, Illinois: Eton Pharmaceuticals. October 6, 2020. Accessed December 23, 2020.
3. Eton Pharmaceuticals reports positive study results for ET-101 (topiramate oral solution). News release. Deer Park, Illinois. Eton Pharmaceuticals. Published March 17, 2020. Accessed December 23, 2020.
4. Topiramate (Topamax) FDA label. Updated October 2012. Accessed December 23, 2020.
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