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.

CS Chronocort Graphic 2

PBPK assisted in determining the final dosing regimen for CAH treatment with Chronocort.

CAH is an orphan condition caused by deficiency of adrenal enzymes needed to produce the steroid hormone cortisol. The block in the cortisol production pathway causes over-production of androgen precursors to cortisol. The condition is congenital and affects both sexes.

CS Chronocort Graphic 1

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