Researchers found that Eton Pharmaceuticals has submitted a request to the FDA to expand the use of their hydrocortisone oral solution, KHINDIVI, to include younger children under five years old. This new formulation has shown bioequivalence to ALKINDI SPRINKLE, a previously approved hydrocortisone treatment. If approved, this could significantly improve treatment options for pediatric patients suffering from adrenal insufficiency, a condition where the adrenal glands do not produce enough cortisol.

This development matters for parents of young children with adrenal insufficiency, as it could provide a vital medication option for those who currently have limited choices. The current formulation of KHINDIVI is already approved for children aged five and older, and expanding its use to younger patients could address the needs of approximately 10,000 pediatric patients in the U.S. who struggle with this serious condition. The ability to administer a ready-to-use liquid solution could also be a game-changer for children who have difficulty swallowing pills.

The FDA’s review process for this submission could lead to an approval as early as the first half of 2027, but it is important to note that this is still an early-stage development. While the bioequivalence results are promising, the final decision will depend on the FDA’s assessment of the application. Parents and caregivers should stay informed about this potential treatment option as it progresses through the regulatory process.

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