FDA Approves First Oral Solution of Topiramate to Treat Epilepsy, Migraines

Author(s):

Originally approved in 1996, the therapy, indicated for the treatment of to partial-onset and tonic clonic seizures, is now available in a liquid formulation.

Amit Patel

The FDA has approved Azurity Pharmaceuticals’ oral formulation of topiramate 25 mg/ml, marketed as Eprontia, for the treatment of various conditions such as epilepsy and migraine, making it the first and only liquid formulation of the therapy to be greenlit.¹

Eprontia can now be used orally as a monotherapy to treat partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older, as an adjunctive therapy for treatment of partial-onset seizures, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome in the same age group, and as a preventive treatment of migraine for patients aged 12 years and older.

"Our ability to address each patient’s needs, with a tailored approach and a proven therapy, is transformative for patients, caregivers, and the healthcare professionals who treat them," Amit Patel, chairman and chief executive officer, Azurity Pharmaceuticals, said in a statement.¹ "EPRONTIA’s ready-to-use liquid formulation provides HCPs a therapy that addresses an unmet medical need."

Topiramate was originally approved under the brand name Topamax in 1996 as a carbonic anhydrase inhibitor medication to treat epilepsy and prevent migraines. In addition to the number of several indications it has, the therapy is also used to treat medication overuse headache and was recommended by the European Federation of Neurological Societies as one of the few medications showing effectiveness for this indication.²

"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,” Michael C. Smith, MD, director, Rush Epilepsy Center, and professor, Department of Neurological Sciences, Rush University Medical Center, said in a statement.¹ "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."

Clinicians have used topiramate off-label to treat bipolar disorder, obesity, binge eating disorder, and as an off-set to weight gain induced from antipsychotic medications. In 2012, the combination of phentermine/topiramate (Qsymia; Vivus) was approved in the US for weight loss.³

Safety label precautions with topiramate include acute myopia and secondary angle closure glaucoma, as well as visual field defects, oligohydrosis and hyperthermia, and metabolic acidosis. Patients may also be susceptible to suicidal behavior and ideation with the concomitant use of antiepileptic drugs, cognitive/neuropsychiatric adverse reactions, fetal toxicity, and serious skin reactions.

REFERENCES

1. Azurity Pharmaceuticals announces FDA approval of Eprontia (topiramate) oral solution. News release. Azurity Pharmaceuticals. November 8, 2021. Accessed November 10, 2021. https://azurity.com/azurity-pharmaceuticals-inc-announces-fda-approval-of-eprontia-topiramate-oral-solution/

2. Evers S, Jensen R. Treatment of medication overuse headache – guideline of the EFNS headache panel. Eur J Neurol. Published online August 11, 2021. Doi:10.1111/j.1468-1331.2011.03497.x

3. Vivus announces FDA-approval of once daily Qsymia (phentermine and topiramate extended-release) capsules CIV. News release. Vivus. July 17, 2012. Accessed November 10, 2021. https://www.prnewswire.com/news-releases/vivus-announces-fda-approval-of-once-daily-qsymia-phentermine-and-topiramate-extended-release-capsules-civ-162810516.html