By Kamal Choudhury
Feb 25 (Reuters) – The U.S. Food and Drug Administration on Wednesday approved Eton Pharmaceuticals’ first-of-its-kind liquid therapy for a rare hormonal disorder, offering a more precise dosing option for families managing a condition that disrupts the body’s ability to retain water.
Shares of the Illinois-based drugmaker rose over 8% in afternoon trading.
The drug, Desmoda, is the first FDA-approved oral liquid formulation of desmopressin for treating central diabetes insipidus, or arginine vasopressin deficiency (AVP-D), a disorder in which patients lack the hormone that regulates water balance, causing excessive urination and thirst.
The ready-to-use 0.05 mg/ml solution eliminates the need for tablet splitting or crushing, allowing doctors to measure precise doses that can be fine-tuned for patients’ needs, a critical advantage in a condition where even small dosing errors can trigger dangerous sodium imbalances.
“Desmoda address serious life-long unmet need for pediatric patients and their caregivers,” said B. Riley Securities analyst Madison El-Saadi.
Eton estimates that more than 13,000 Americans live with the condition, including up to 4,000 children.
The company plans to launch the drug on March 9 and expects peak sales of $30 million to $50 million annually, with patent protection extending through 2044.
“Desmoda was approved for patients of all ages, which is broader than the pediatric-centric positioning we and the Street were primarily modeling,” said El-Saadi, adding that he expects a strong launch with pent-up demand playing out over the next three to six months.
El-Saadi expects insurers to provide favorable coverage given the small patient population and well-established clinical need.
The drug carries warnings about potential side effects including dangerously low sodium levels in the blood, fluid retention and allergic reactions. Patients need careful monitoring during treatment, particularly children and older adults who face higher risks.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Alan Barona)
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