FDA Approves Eton's Formulated Topiramate For Seizure, Migraine Treatment

Eton Pharmaceuticals Inc ETON 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.
Related content: Benzinga's Full FDA Calendar.
Price Action: ETON shares are down 3.66% at $6.06 during the premarket session on the last check Monday.