Infacort® is Diurnal’s most clinically advanced product targeting AI (including CAH) in children under six years of age. In Q3, 2016 Infacort® successfully completed a European Phase III clinical trial for AI (including CAH) and subsequently in Q4,2016 the company submitted a market authorisation application to the European Medicines Agency. Phase III clinical trials in the US are expected to commence in 2018 subject to FDA feedback.
Infacort® is an immediate-release hydrocortisone preparation that has been specifically designed to meet the dosing needs of children under six years of age for whom no licensed, child-friendly products exist in Europe or in the US. Infacort® is manufactured using commercially proven technology in four doses: 0.5mg, 1mg, 2mg and 5mg, in order to give maximum flexibility to clinicians in tailoring the treatment to the child. Taste-masking excipients that are acceptable for paediatric use eliminate the bitter taste of hydrocortisone, potentially increasing compliance. Formal stability studies are in progress and the aim is for Infacort® to have a shelf life exceeding two years at market authorisation; this would be superior to existing unlicensed hydrocortisone products.
Diurnal expects Infacort®, if approved, to be the first licensed treatment for CAH and AI in children under six years of age in Europe (0 to 16 years of age in the US). Currently, pharmacists often compound (grind) hydrocortisone tablets to a fine powder and reconstitute it in individual capsules or sachets to achieve the lower doses required for children. This compounding is highly variable and often results in inaccurate dosing3.
3 Article by D. Kauzor, S. Spielmann, H. Brosig, R. Ross, O. Blankenstein and C Kloft entitle ‘Medication safety study investigating hydrocortisone individually and extemporaneously compounded capsules for paediatric use in CAH’ published in association with Clinical Pharmacy.