Infacort has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of pediatric adrenal insufficiency (0 through 16 years of age). Infacort is a new formulation being developed by Diurnal Limited, a specialty pharmaceutical company based in Sheffield, UK. Adrenal insufficiency is a rare disease characterized by a deficiency in cortisol, an essential hormone for regulating metabolism and the response to stress. Currently, there is no licensed hydrocortisone preparation for children with this condition. Infacort is a formulation based on the company’s patented technology that allows the release of cortisol in a reliable and consistent manner. It is currently in phase III clinical trial to evaluate its safety and efficacy in pediatric adrenal insufficiency.
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