Eton Pharmaceuticals has received U.S. Food and Drug Administration approval for DESMODA (desmopressin acetate) Oral Solution, a new treatment option for central diabetes insipidus. The product represents the first FDA-approved oral liquid formulation of desmopressin, addressing a clinical need for flexible dosing without tablet manipulation. The company plans to launch DESMODA on March 9, with commercial availability expected to capture market share from existing tablet-based alternatives.
The approval represents a significant milestone for Eton's portfolio, as the product addresses an estimated patient population of more than 13,000 individuals in the United States, including 3,000 to 4,000 pediatric patients. DESMODA's liquid formulation enables precise dose adjustment and eliminates the need for tablet splitting, potentially improving dosing accuracy and patient compliance across demographic groups.
Eton projects peak annual sales of $30 million to $50 million for DESMODA, supported by patent exclusivity extending through 2044. The product's market positioning capitalizes on the unmet need for an easy-to-dose liquid formulation in a specialized but consistent patient population requiring long-term desmopressin therapy.