zonisamide oral suspension (ET-104) / Eton Pharma, Azurity Pharma - LARVOL DELTA

Zonisamide oral suspension as adjunctive therapy for treating partial seizures in adults and in pediatric patients aged 16 years and older with epilepsy. (PubMed, Expert Rev Neurother) - "The ZNS oral suspension allows additional flexibility for epilepsy management, particularly for patients unable to swallow capsules. Its bioavailability and specific formulation may improve adherence and seizure control."

Journal • Review • CNS Disorders • Epilepsy • Pediatrics

Study of the Pharmacokinetics, Safety, and Tolerability of ZONISADE in Children 1 Month to 17 Years of Age with Partial-onset Seizures (clinicaltrials.gov) - P4 | N=40 | Not yet recruiting | Sponsor: Azurity Pharmaceuticals | Trial completion date: Jun 2025 ➔ Mar 2026 | Initiation date: Sep 2024 ➔ Feb 2025 | Trial primary completion date: Jun 2025 ➔ Mar 2026

Trial completion date • Trial initiation date • Trial primary completion date • CNS Disorders • Epilepsy

Study of the Pharmacokinetics, Safety, and Tolerability of ZONISADE in Children 1 Month to 17 Years of Age With Partial-onset Seizures (clinicaltrials.gov) - P4 | N=40 | Not yet recruiting | Sponsor: Azurity Pharmaceuticals

New P4 trial • CNS Disorders • Epilepsy

Bioequivalence of Different Formulations of Zonisamide Oral Suspensions: A Short Review. (PubMed, Patient Prefer Adherence) - "As a narrow therapeutic window drug, zonisamide requires precision in dosing, which could be achieved only with dosage forms with established bioavailability, efficacy, and safety. In order to avoid underdosing and toxicity with zonisamide oral suspensions and utilize their full therapeutic potential, it is necessary to perform bioequivalence studies with each variation of extemporaneously compounded oral suspension and also clinical trials with both commercial and extemporaneous oral suspensions of zonisamide."

Journal • Review • CNS Disorders • Epilepsy • Pediatrics

Eton Pharmaceuticals Reports Second Quarter 2022 Financial Results (GlobeNewswire) - "Second Quarter Financial Results...Cash Position: As of June 30, 2022, the company had cash of $17.0 million. The company is entitled to receive an additional $5.0 million milestone payment upon the launch of the recently approved Zonisade product."

Commercial • CNS Disorders • Epilepsy

AZURITY PHARMACEUTICALS, INC. ANNOUNCES FDA APPROVAL OF ZONISADE (zonisamide oral suspension) (BioSpace) - "Azurity Pharmaceuticals, Inc...announced the U.S. Food and Drug Administration (FDA) approval of ZONISADE™ (zonisamide oral suspension), 100 mg/5 mL as adjunctive therapy for the treatment of partial seizures in adults and pediatric patients aged 16 years and older with epilepsy."

NDA • CNS Disorders • Epilepsy

"$ETON Eton Pharmaceuticals Announces FDA Approval of ZONISADE™ (Zonisamide Oral Suspension) https://t.co/8w3FA8JiMA #fdaapproval" (@stock_titan)

FDA event

Eton Pharmaceuticals Reports First Quarter 2022 Financial Results (GlobeNewswire) - "Zonisamide Oral Suspension. In April, the product’s contract manufacture received notice that the January 2022 FDA site inspection has been officially closed and the facility was deemed ready for commercial manufacturing. As a result, Eton expects the application to be approved on its newly assigned PDUFA date of July 18th."

PDUFA date • CNS Disorders • Epilepsy

Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Zonisamide Oral Suspension (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 zonisamide oral suspension. The application has been assigned a Prescription Drug User Fee Act (PDUFA) date of May 29, 2021....Zonisamide is one of Eton’s three neurology-focused oral liquid product candidates that have been submitted to the FDA, and all three product candidates are expected to be approved and launched in 2021."

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

"$ETON FDA Accepts NDA for Zonisamide Oral Suspension. PDUFA 05/29/21" (@BioStocks)

NDA • PDUFA date