The Food and Drug Administration (FDA) has approved Alkindi® Sprinkle (hydrocortisone oral granules; Eton Pharmaceuticals) as replacement therapy in pediatric patients with adrenocortical insufficiency.

Alkindi Sprinkle contains immediate-release oral hydrocortisone granules designed for the dosing needs of pediatric patients with adrenocortical insufficiency; most of these patients require significantly lower doses than the currently available 5mg tablet formulation of hydrocortisone. The approval of Alkindi Sprinkle is supported by use in pediatric patients for adrenocortical insufficiency with another hydrocortisone product, along with supportive pharmacokinetic and safety data in 24 pediatric patients with adrenocortical insufficiency.

Alkindi Sprinkle is supplied in 4 dosage strengths: 0.5mg, 1mg, 2mg, and 5mg. The oral granules are contained within capsules that should be opened and administered to the patient either directly on the tongue or by pouring the granules onto a spoon and placing in the patient’s mouth.

Alternatively, the granules may be mixed with cold or room temperature soft food and subsequently swallowed within 5 minutes to avoid a bitter taste. The Alkindi Sprinkle capsules should not be swallowed. Additionally, the granules should not be administered via nasogastric or gastric tubes as they may cause tube blockage.


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“We are excited to offer an FDA-approved product that enables low dosing and administration of hydrocortisone to pediatric patients,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “We look forward to making the product available to patients in the coming months.”

For more information visit etonpharma.com.

References

  1. Eton Pharmaceuticals announces FDA approval of orphan drug Alkindi® Sprinkle (hydrocortisone) as replacement therapy in pediatric patients with adrenocortical insufficiency. https://www.globenewswire.com/news-release/2020/09/29/2101010/0/en/Eton-Pharmaceuticals-Announces-FDA-Approval-of-Orphan-Drug-ALKINDI-SPRINKLE-hydrocortisone-as-Replacement-Therapy-in-Pediatric-Patients-with-Adrenocortical-Insufficiency.html. Accessed September 30, 2020. 
  2. Alkindi Sprinkle [package insert]. Deer Park, IL: Eton Pharmaceuticals; 2020.