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Pharmacodynamic studies of nasal tetracosactide with salivary glucocorticoids for a non-invasive short synacthen test

Journal of Clinical Endocrinology and Metabolism Jun 27, 2020

Elder CJ, Vilela R, Johnson TN, et al. - In this investigation involving 36 healthy adult males and 24 healthy children, researchers sought to establish a nasally administered Short Synacthen Test (SST) with measurement of salivary glucocorticoids to evaluate the adrenal response. Five studies were conducted: four open-label, sequence-randomised, crossover, pharmacodynamic studies testing six doses/formulations and a repeatability study. In addition, the paediatric study conducted a pharmacokinetic analysis using the formulation chosen, 500 μg tetracosactide with mucoadhesive chitosan, Nasacthin003. All six nasal formulations were administered using a CE marked atomisation device. The intravenous comparators were 250 µg or 1 µg SST. According to findings, nasal administration of Nasacthin003 generates equivalent plasma cortisol values to the 250 μg intravenous SST and provides a non-invasive adrenal insufficiency test with a measurement of salivary cortisol or cortisone at 60 minutes.

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