Eprontia (topiramate oral solution) / Eton Pharma, Azurity Pharma - LARVOL DELTA

Eton Pharmaceuticals Reports Fourth Quarter 2021 Financial Results (GlobeNewswire) - "Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2021 were moderate at $0.7 million compared to $3.4 million in the prior-year period. R&D expenses in the fourth quarter of 2020 were elevated due to a $1.4 million FDA filing fee for topiramate oral solution...Cash Position: Cash and cash equivalents were $14.4 million as of December 31, 2021. Eton received the $5.0 million EPRONTIA commercial launch milestone payment in early January."

Commercial • CNS Disorders • Epilepsy

Drugs for alcohol use disorder. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Addiction (Opioid and Alcohol)

Eton Pharmaceuticals and Azurity Pharmaceuticals, Inc. Announce FDA Approval of EPRONTIA (topiramate) Oral Solution (GlobeNewswire) - "Eton Pharmaceuticals, Inc...and Azurity Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved 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....Eton will receive a $5 million milestone payment upon EPRONTIA’s commercial launch, a royalty on net sales, and potential commercial milestones."

NDA • CNS Disorders • Epilepsy • Migraine • Pain

"$ETON Eton Pharmaceuticals and Azurity Pharmaceuticals, Inc. Announce FDA Approval of EPRONTIA™ (topiramate) Oral Solution https://t.co/mh7MHxcR5T #fdaapproval" (@stock_titan)

FDA event

Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Topiramate Oral Solution (GlobeNewswire) - "Eton Pharmaceuticals, Inc....today announced the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s new drug application (NDA) for topiramate oral solution. The application has been assigned a Prescription Drug User Fee Act (PDUFA) date of August 6, 2021. The application was submitted for three indications, including: monotherapy for treatment of partial-onset or primary general tonic-clonic seizures in patients two years age and older; adjunctive therapy for treatment of partial-onset seizures...in patients two years of age and older; and as preventative treatment of migraine in patients 12 years of age and older. Topiramate is one of Eton’s three neurology-focused oral liquid product candidates...and all three product candidates are expected to be approved and launched in 2021."

Launch US • NDA • PDUFA date • CNS Disorders • Epilepsy • Migraine • Pain

Eton Pharmaceuticals Announces First Quarter 2020 Financial Results (GlobeNewswire, Eton Pharmaceuticals) - "ET-101 (Topiramate Oral Solution). During the quarter, Eton announced successful bioequivalence study results for ET-101. Eton expects to submit the product’s NDA in the second half of 2020."

Clinical data • NDA • Infectious Disease