• Eton Pharmaceuticals Inc and Azurity Pharmaceuticals Inc have announced that the FDA has approved Eprontia (topiramate) oral solution, 25mg/mL.
• Eprontia has been approved as a monotherapy for partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older.
• The drug has also been approved as adjunctive therapy for 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.
• Eprontia is the first oral liquid formulation of topiramate to be approved by the FDA.
• Azurity will be responsible for commercializing the product, and it anticipates product availability by the end of 2021.
• Eton will receive a $5 million milestone payment upon Eprontia's commercial launch, a royalty on net sales, and potential commercial milestones.
• Price Action: ETON shares are down 3.66% at $6.06 during the premarket session on the last check Monday.