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.
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