Eton Pharma gets US FDA approval for orphan drug ALKINDI SPRINKLE (hydrocortisone)

Eton Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved ALKINDI SPRINKLE (hydrocortisone) oral granules as replacement therapy for adrenocortical insufficiency (AI) 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.

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 paediatric AI in neonates to children under eight years of age. Prior to the approval of ALKINDI SPRINKLE, oral hydrocortisone was only FDA-approved in tablet formulations of 5 mg and stronger. Many paediatric 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, to individualise dosing based on each patient’s needs in accordance with the instructions for dosage and administration.

Eton expects ALKINDI SPRINKLE to be commercially available in the fourth quarter of 2020.