In July 2021, the European Commission (EC) approved the marketing authorization for Efmody® (hydrocortisone modified-release hard capsules – development name Chronocort®) to treat adult and adolescent patients (12 years and older) with CAH. Efmody contains the active substance hydrocortisone and is a hybrid medicine, meaning it has a different use and is available in different strengths as capsules formulated to release the active substance over a prolonged period (modified release).
To facilitate clinical development, Certara scientists used the Simcyp Simulator to perform physiologically-based pharmacokinetic (PBPK) modeling and simulation for the endogenous hormone cortisol (hydrocortisone) in healthy adults and children and adults with adrenal insufficiency. The model predicted immediate-release hydrocortisone pharmacokinetics in adults across the dose range. The model also accurately predicted pharmacokinetic parameters for modified-release formulations after single and multiple dosing. Predicted modified-release formulation pharmacokinetics (PK) in 12 to 18-year-olds was like adults.