Alkindi Sprinkle Approved for Pediatric Hormone Disorder

September 30, 2020 – The U.S. FDA has approved Alkindi® Sprinkle (hydrocortisone) oral granules, manufactured by Eton Pharmaceutical, to provide replacement therapy for pediatric patients who have adrenocortical insufficiency. Alkindi Sprinkles are the first and only FDA-approved granular hydrocortisone formulation specifically designed for use in children under this indication.

Pediatric adrenocortical Insufficiency is a rare, life-threatening disease that occurs when a patient’s body cannot create and release cortisol, a naturally occurring hormone. In some cases, the body is also unable to produce and release an additional hormone called aldosterone. Cortisol is necessary to aid in recovery from illness and injury, and also impacts blood sugar levels and blood pressure. Aldosterone is needed to balance the levels of water and salt in the body. Patients who have adrenocortical insufficiency must receive cortisol replacement therapy on a daily basis.

A current standard of care for adrenocortical insufficiency, hydrocortisone was previously only FDA approved for oral administration in tablet formulations of 5mg and stronger. This limited the ability to customize doses for pediatric patients and perform precise titration of dosing to meet these patient’s individual needs. Alkindi Sprinkle will be available in 0.5mg, 1mg, 2mg, and 5mg strengths.

Dosing should be individualized for each patient, using the lowest possible dosage. The recommended starting dose is 8-10mg/m 2 of body surface area per day (divided into 2-3 doses taken 2-3 times per day). However, a lower starting dose may be sufficient in patients who have residual but decreased endogenous cortisol production. Alkindi Sprinkle can be administered by pouring the granules directly onto the patient’s tongue, pouring the granules onto a spoon and placing it in the patient’s mouth, or sprinkling the granules onto a spoonful of cold or room temperature soft food such as yogurt or fruit puree.

Eton has launched the product at a wholesale acquisition cost (WAC) of $1,397.28 per bottle of 50 capsules.