In order to conduct clinical studies, AcuCort must gain approval from both the ethical committee and the regulatory authority in the country where the study will be performed. Together with the obtained approval from the ethical committee, today's news means that the study that will be the basis for an application for marketing approval in the US can be started.

"A further milestone has been achieved with SUKL's approval of our study application. The decision enables us to start this important study already in January," says Mats Lindfors, CEO of AcuCort.

About glucocorticoids
Every year millions of patients across the world use medicines containing glucocorticoids, for example against allergy and viral croup. Also cancer patients suffering from nausea and vomiting in connection with chemotherapy (CINV) use this type of drug. One big disadvantage is that these drugs are not perceived to be user-friendly or require medical staff. First having to dissolve the tablets in water can be very awkward in an acute situation, for the sufferers as well as for other persons helping them. The sufferer may have difficulties swallowing, and thus a fast-dissolving film to be placed on the tongue, with the same effect as the tablet, may have a wide application area.

This information is information that AcuCort AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, on January 23, 2019.