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TAIN Reports Successful Infacort Trial

Posted on Wednesday, 04/Dec/2013

Cardiff, UK.  The TAIN Consortium funded by the European Commission (FP7-HEALTH No: 281654) announced that a clinical trial of Infacort® (immediate release hydrocortisone granules for paediatric use) successfully achieved its primary outcome of demonstrating bioequivalence versus immediate release hydrocortisone tablets. Infacort® was safe and well tolerated in 16 healthy adult volunteers.  The successful completion of this trial enables progression to a registration trial of Infacort® in the target paediatric population (children aged less than 6 with suffering from adrenal insufficiency) according to the Paediatric Investigation Plan approved by the European Medicines Agency (EMEA-001283-PIP01-12).  It is hoped that patients participating in the next Infacort® study will be one of first to be enrolled in the I-CAH registry.  Further information can be found at www.tain-project.org