Eton Pharmaceuticals announces FDA approval for Desmoda Oral Solution

Eton Pharmaceuticals (ETON) announced the U.S. Food and Drug Administration approval of a New Drug Application for Desmoda Oral Solution for the management of central diabetes insipidus, also known as arginine vasopressin deficiency, as antidiuretic replacement therapy for patients of all ages. Desmoda is the first and only FDA-approved oral liquid formulation of desmopressin, developed to support precise, individualized dosing in a disease where careful titration is essential to maintaining water balance. Desmoda is supplied as a ready-to-use oral solution that does not require tablet splitting, crushing, refrigeration, mixing, or shaking. Eton estimates that there are more than 13,000 patients with central diabetes insipidus in the U.S., including approximately 3,000-4,000 pediatric patients. The company expects product peak sales of $30M-$50M annually.