FDA Approves Liquid Formulation of Seizure Medication

The FDA has approved Azurity Pharmaceuticals’ Eprontia (topiramate), an oral solution that is used as a monotherapy and as adjunctive therapy for patients two years of age and older with partial-onset or primary tonic-clonic seizure, as well as to prevent seizures. Eprontia 25 mg/mL is a ready-to-use liquid medication for those who have trouble swallowing pills.

“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,” Michael C. Smith, M.D., said in a statement. Smith is director of Rush Epilepsy Center and professor in the Department of Neurological Sciences at Rush University Medical Center.

Azurity acquired Eprontia and two other neurology products, lamotrigine and zonisamide, from Eton Pharmaceuticals in February 2021. Eton developed the products, which are liquid formulations, to treat seizure. Both are under review at the FDA.

Azurity will be responsible for commercialization. Eton will receive a $5 million milestone payment upon launch of Eprontia, a royalty on net sales, and potential commercial milestones.

Globally, an estimated 65 million people have epilepsy, and 1 billion suffer from migraine. In the United States, one in 26 people will develop epilepsy at some point during their lifetime and about 39 million people suffer from migraine.