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.

 

References:

http://www.diurnal.co.uk/products-pipeline/infacort/