Eton Pharmaceuticals Submits New Drug Application for Desmopressin Oral Solution
Deer Park, Monday, 28 April 2025.
Eton Pharmaceuticals submits an NDA for Desmopressin Oral Solution, potentially making it the only FDA-approved oral liquid for central diabetes insipidus in children, pending a 10-month review.
Eton Pharmaceuticals Enters Regulatory Phase with NDA for ET-600
Eton Pharmaceuticals, Inc. (NASDAQ: ETON) has officially submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for ET-600, a proprietary desmopressin oral solution intended for the treatment of central diabetes insipidus. This submission marks a critical regulatory milestone for the company. The submission, announced on 28 April 2025, initiated a potential timeline that could see ET-600 launched as the only FDA-approved oral liquid formulation of desmopressin for pediatric patients by the first quarter of 2026, pending a 10-month FDA review period [1].
Potential Impacts on the Pharmaceutical Market
If approved, ET-600 could significantly impact the pharmaceutical market by addressing a need for small, precise, and titratable doses of desmopressin, particularly benefiting approximately 3,000 pediatric patients in the United States affected by central diabetes insipidus [1]. This precision in dosing is crucial, given the nature of the condition and the current lack of approved liquid formulations. The approval can potentially cement Eton’s position in the market, leveraging their patented product with an expiration set for 2044, and could drive further innovation and competition in this niche area [1].
Bioequivalence and Future Considerations
In a bioequivalence study conducted on 75 human subjects, ET-600 demonstrated pharmacokinetic equivalence to the FDA-approved reference product, thereby reinforcing its efficacy and safety profile [1]. The implications of such findings suggest a streamlined approval process, though developers remain cautious due to the inherent uncertainties in drug commercialization and regulatory pathways. Looking forward, Eton has initiated preparations for a possible launch, emphasizing their commitment to addressing pediatric demands but also acknowledging the risks and uncertainties present in drug development [1].