In the development of AcuCort’s first approved drug Zeqmelit®, the benefits of the anti-inflammatory substance dexamethasone and the user-friendly mouth film have been combined for rapid availability and relief in emergency situations. The mouth film quickly dissolves when it is placed on the tongue. The drug does not require water in the administration, which is important in emergency situations and for patients who have difficulty swallowing tablets, for example children, the elderly or very sick patients.
AcuCort has conducted four bioequivalence studies; one as “proof of concept” (conceptional evidence of the drug’s effect in humans) and one in preparation for the application for market authorization in the EU. The bioequivalence studies show that the effect of the fast-soluble mouth film Zeqmelit® is comparable to the corresponding dose of dexamethasone in tablet form.
Zeqmelit® has reached three years of stability data, which means that the drug achieves at least three years shelf life. A confirmed shelf life of three years is a great advantage, among other things in relation to the distribution of the drug and important for the upcoming commercialization.
AcuCort’s technical know-how regarding the combination of dexamethasone and mouth films is protected by two patents.