Eton Pharmaceuticals announces availability of ALKINDI SPRINKLE in U.S.

Eton Pharmaceuticals announced the full availability of ALKINDI SPRINKLE for sale and distribution in the United States. The U.S. Food and Drug Administration has approved ALKINDI SPRINKLE oral granules as replacement therapy for Adrenocortical Insufficiency in children under 17 years of age. ALKINDI SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for the treatment of adrenocortical insufficiency specifically designed for use in children. ALKINDI SPRINKLE will be available exclusively through AnovoRx, a specialty pharmacy dedicated to serving patients with rare and chronic conditions. AnovoRx will administer the Eton Cares Program in partnership with Eton Pharmaceuticals. The program will complete prescription fulfillment, insurance benefits investigation, educational support, aid qualified patients to obtain financial assistance along with other services designed to help patients access treatment. The FDA approval of ALKINDI SPRINKLE was supported by six clinical studies, including the first and only interventional Phase III study of oral hydrocortisone for Pediatric AI in neonates to children under eight years of age. ALKINDI SPRINKLE achieved significant increases in cortisol levels from baseline and was found to be well tolerated with no serious adverse events. Prior to the approval of ALKINDI SPRINKLE, oral hydrocortisone was only FDA-approved in tablet formulations of 5 mg and stronger. Many pediatric patients require significantly lower doses and the flexibility of precision titration. ALKINDI SPRINKLE will be available in 0.5-mg, 1-mg, 2-mg, and 5-mg strengths, allowing clinicians greater flexibility to individualize dosing based on each patient's needs in accordance with the instructions for dosage and administration.