Eton Pharmaceuticals, Inc. (ETON) Launches Game-Changer for Adrenal Insufficiency

Eton Pharmaceuticals, Inc. (NASDAQ:ETON) has received FDA approval for KHINDIVI, the first and only hydrocortisone oral solution available in the United States, marking a major milestone for pediatric care. Designed for children aged five and older with adrenocortical insufficiency, a rare disorder where the adrenal glands do not produce enough cortisol, KHINDIVI offers a 1mg/ml ready-to-use liquid formulation. This eliminates the need for splitting or crushing tablets and allows for precise, incremental dosing tailored to each child’s needs.

The solution does not require refrigeration, mixing, or shaking, making it especially suitable for patients who have trouble swallowing pills or need administration via a gastric tube.

A clinical researcher in a lab examining a new biopharmaceutical product.

Eton Pharmaceuticals, Inc. (NASDAQ:ETON) expects to launch KHINDIVI commercially the week of June 2, with combined peak sales from KHINDIVI and its companion product, ALKINDI SPRINKLE, projected to exceed $50 million annually.

The medication will be distributed exclusively through Anovo, a specialty pharmacy, and supported by the Eton Cares Program, which provides prescription fulfillment, insurance support, educational resources, and co-pay assistance. This FDA approval is seen as a significant advancement for families and clinicians managing pediatric adrenal insufficiency, offering a new, accurate, and accessible treatment option.

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