Eton will get a milestone payment of $5m upon commercially launching Eprontia. Credit: Gerd Altmann / Pixabay.

The US Food and Drug Administration (FDA) has granted approval to Eton Pharmaceuticals and Azurity Pharmaceuticals’ Eprontia (topiramate) oral solution to treat seizures and migraines.

A liquid formulation of topiramate, Eprontia is now indicated as a single agent to treat partial-onset or primary generalised tonic-clonic seizures in individuals aged two years and above.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The oral solution is also approved as an adjunctive treatment for partial-onset seizures, primary generalised tonic-clonic seizures or seizures linked with Lennox-Gastaut syndrome in people aged two years and above.

Eton noted that Eprontia can be used as a preventive therapy for migraine in patients aged 12 years and above.

Azurity Pharmaceuticals chairman and CEO Amit Patel said: “This is a transformative day for patients living with epileptic seizures and migraines and their families and caregivers.

“We take great pride in developing therapies that give healthcare practitioners the ability to treat patients whose needs are not served by available medicines.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

With the latest development, Eprontia is claimed to have become the first-ever oral liquid formulation of topiramate to obtain FDA approval.

Azurity will market the oral solution, which will be made available by this year-end, while Eton will get a milestone payment of $5m upon the commercial launch of the solution, besides a royalty on net sales and payments on achieving potential commercial milestones.

Eton Pharmaceuticals CEO Sean Brynjelsen said: “We are proud to see the approval of Eprontia and we believe it will address a critical unmet need for patients requiring adherence, compliance and precision dosing with a liquid formulation.

“We look forward to continuing to work with Azurity to achieve additional approvals from our CNS portfolio partnership.”