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Clinical development

EU

The analysis of the study AcuCort001, conducted in 2013, regarding pharmacokinetics and bioavailability showed that ISICORT® is bioequivalent to the reference product Fortecortin tablet. The analysis of the bioequivalence study AcuCort002, conducted in 2018, showed, like the 2013 study, that ISICORT® is bioequivalent to the reference product Fortecortin tablet.

The study AcuCort002 was conducted with ISICORT® from batches produced on a commercial scale according to good manufacturing practice, GMP. The study was part of the approved application for market approval in Sweden, which is a first step towards broader approval within the EU.

ISICORT® is an approved and fully developed drug and AcuCort plans to, together with the healthcare system, implement and document the use of the drug product in patients with the aim of increasing knowledge about the treatment.

United States

In 2018, the FDA required that AcuCort conduct two bioequivalence studies, to be included in an application for market approval in the United States. AcuCort has completed the required studies. One study was performed with fasting participants and one with non-fasting participants. The studies have been conducted with ISICORT® from batches produced on a commercial scale according to good manufacturing practice, GMP.

The analysis of the bioequivalence study AcuCort003, conducted in 2019, with fasting participants, showed that ISICORT® is bioequivalent to the US reference product West-Ward Pharmaceuticals 6 mg Dexamethasone Tablet USP. The bioequivalence study AcuCort004, conducted in 2019, with non-fasting participants, showed that ISICORT® is bioequivalent to the US reference product West-Ward Pharmaceuticals 6 mg Dexamethasone Tablet USP for two of the three requested parameters. An investigation conducted by an expert group has concluded that the outcome meets the requirements for applying for market approval in the United States. In addition, the conclusion has been confirmed by two independent international regulatory expert bodies.