Core Insights - Eton Pharmaceuticals has successfully completed a pivotal bioequivalence study for its patented oral solution ET-600, which is intended for the treatment of central diabetes insipidus [1][2] - The company plans to submit a New Drug Application (NDA) to the FDA in April 2025, with the potential for ET-600 to become the only FDA-approved oral liquid formulation of desmopressin if approved [2][3] Company Overview - Eton Pharmaceuticals is focused on developing and commercializing treatments for rare diseases, currently offering seven commercial products and four additional candidates in late-stage development [5] - ET-600 is a proprietary formulation of desmopressin oral solution, with a patent extending to 2044, aimed at addressing the needs of approximately 3,000 pediatric patients in the U.S. suffering from central diabetes insipidus [4][5] Study Details - The bioequivalence study involved 75 human subjects and demonstrated pharmacokinetic equivalence to the FDA-approved reference product [2] - The study was designed as an open-label, balanced, randomized, single-dose, three-treatment, three-sequence, three-period, three-way crossover trial [2] Future Plans - Eton anticipates launching ET-600 in the first quarter of 2026, following the NDA submission and potential approval [3] - The company has initiated pre-launch commercial readiness activities in preparation for the product's market entry [3]
Eton Pharmaceuticals Announces Positive Pivotal Clinical Study Results for Product Candidate ET-600