Alkindi® (hydrocortisone granules in capsules for opening) is Diurnal’s first commercialised medicine and is indicated as replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old)1. Alkindi was approved through the centralised paediatric use marketing authorisation (PUMA) route in the European Union in 2018. Phase III clinical trials in the US are expected to commence in 2018 subject to FDA feedback.
Alkindi is an immediate-release hydrocortisone preparation that has been specifically designed to meet the dosing needs with adrenal insufficiency for whom no licensed, child-friendly products exist in Europe or 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 dosing2. Alkindi 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. Alkindi has a shelf life exceeding two years which is significantly longer than that of existing unlicensed hydrocortisone products.
2. Neumann et al 2017 Quality of compounded hydrocortisone capsules used in the treatment of children. European Journal of Endocrinology 177, 239–242