The U.S. Food and Drug Administration (FDA) has approved Eton Pharmaceuticals and Azurity Pharmaceuticals’ EPRONTIA™ (topiramate) oral solution, 25mg/mL.
EPRONTIA™ has been approved as a monotherapy for treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; an adjunctive therapy for 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 as a preventive treatment of migraine in patients 12 years of age and older.
“This is a transformative day for patients living with epileptic seizures and migraines and their families and caregivers,” said Amit Patel, Chairman and CEO of Azurity Pharmaceuticals. “We take great pride in developing therapies that give healthcare practitioners the ability to treat patients whose needs are not served by available medicines.”
EPRONTIA™ is claimed to be the first oral liquid formulation of topiramate to be approved by the FDA.
Azurity will be responsible for commercializing the product and anticipates product availability before year end. Eton will receive a $5 million milestone payment upon EPRONTIA’s commercial launch, a royalty on net sales, and potential commercial milestones.
“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,” added Sean Brynjelsen, CEO of Eton Pharmaceuticals.