NDA Submitted for Topiramate Oral Solution for 3 Indications

Sean Brynjelsen, MBA, MS

Eton Pharmaceuticals announced that they have submitted a new drug application (NDA) for topiramate oral solution (ET-101) to the FDA for 3 indications, related to epileptic seizures and migraine.¹

The indications included 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.

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

The agent will aim to be the first and only FDA-approved liquid formulation of topiramate. Furthermore, 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.

READ MORE: Soticlestat Reduces Seizure Frequency in Rare Epilepsies

In March, Eton announced results from a study of topiramate which demonstrated its bioequivalence to Janssen’s Topamax in healthy male subjects under fasting conditions. Researchers found 90% confidence intervals for all pharmacokinetic parameters all within the 80% to 125% bioequivalence criteria. Additionally, a separate food effect study conducted under federal conditions proved that the bioavailability of the drug is not impacted by food intake.²

Topiramate, as Topamax, was first approved to treat various forms of epilepsy in adults and children in 1996. It was approved in 25-, 50-, 100-, and 200-mg tablet forms and 15- and 25-mg sprinkle capsule forms.³ 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.

The most common adverse events (AEs) with the agent in controlled trials were paresthesia, anorexia, weight decrease, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, difficulty with memory, difficulty with concentration/attention, cognitive problems, mood problems, fever, infection, and flushing.

In addition to topiramate, Eton currently is still developing ET-105, its lamotrigine oral suspension for the treatment of epilepsy and bipolar disorder, and ET-104, a proprietary oral liquid formulation of an undisclosed molecule frequently used to treat a severe neurological condition.

REFERENCES

1. 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 October 12, 2020. globenewswire.com/news-release/2020/10/06/2104593/0/en/Eton-Pharmaceuticals-Submits-New-Drug-Application-to-the-FDA-for-Topiramate-Oral-Solution-ET-101.html

2. Eton Pharmaceuticals reports positive study results for ET-101 (topiramate oral solution). News release. Deer Park, Illinois. Eton Pharmaceuticals. Published March 17, 2020. Accessed October 12, 2020. finance.yahoo.com/news/eton-pharmaceuticals-reports-positive-study-120010268.html.

3. Topiramate (Topamax) FDA label. Updated October 2012. Accessed October 12, 2020. accessdata.fda.gov/drugsatfda_docs/label/2012/020844s041lbl.pdf