Crossject: First injections of ZENEO Midazolam for the clinical bioequivalence study

Photo credit © Reuters

( — Crossject a “specialty pharma” which is soon to develop and market a portfolio of combined drugs dedicated to emergency situations, announces the first injections of ZENEO Midazolam for the clinical bioequivalence study.

Crossject initiates its clinical bioequivalence study for ZENEO Midazolam with the first injections, the data of which will be presented in the Marketing Authorization (AMM) file.
The aim of this study is to compare, in healthy subjects, the plasma concentration of an injection of ZENEO Midazolam with that of a syringe fitted with a conventional intramuscular needle filled with the regulatory reference drug midazolam. As a reminder, the previous clinical bioequivalence study for ZENEO Methotrexate1 demonstrated the equivalence of subcutaneous injection.

To assess bioequivalence, the two main criteria are: the area under the curve – which represents the dose of drug received by the subject, which must be between 80% and 125% of that observed for the reference drug – and the maximum peak concentration observed in plasma (Cmax).
All injections are expected to be completed within the next two months. Full results of the bioequivalence study are expected in the fall…

Patrick Alexandre, Chairman of the Management Board of Crossject, comments: “We are pleased that the pivotal clinical study for ZENEO Midazolam has started. This is an important step, as it is part of the evaluation of the application for obtaining Marketing Authorizations. The results are expected in the fall”.


Source link -87