Eprontia Oral Solution Approved for Partial-Onset, Primary Generalized Tonic-Clonic Seizures

The NDA submission includes results from a clinical trial program that included over 1900 patients.
Eprontia is approved for the treatment of partial-onset or primary generalized tonic-clonic seizures and migraine prevention.

The Food and Drug Administration (FDA) has approved Eprontia (topiramate) oral solution, the first liquid formulation of topiramate.

Eprontia is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age or older; adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older; and preventive treatment of migraine in patients 12 years of age and older.

Eprontia is a ready-to-use solution for oral administration containing 25mg/mL of topiramate. The efficacy and safety of Eprontia was based on the relative bioavailability of Eprontia compared with topiramate sprinkle capsules in healthy participants. The topiramate sprinkle capsules have comparable bioavailability to topiramate tablets.

The product will be supplied in a 473mL bottle.

“I am pleased that there will now be an FDA-approved liquid formulation of topiramate for patients who may require or prefer a liquid formulation,” said Michael C. Smith, MD, Director, Rush Epilepsy Center, and Professor, Department of Neurological Sciences, Rush University Medical Center. “Clinical challenges have existed for years for clinicians looking for a high quality, predictable formulation option of topiramate to effectively meet the varied needs of patients and caregivers.”


Azurity Pharmaceuticals, Inc. announced FDA approval of Eprontia (topiramate) oral solution. News release. Azurity Pharmaceuticals, Inc. Accessed November 8, 2021. https://azurity.com/azurity-pharmaceuticals-inc-announces-fda-approval-of-eprontia-topiramate-oral-solution/