(Boursier.com) — Crossject announces the positive results of its clinical study with Zeneo midazolam. This 4-period, cross-over and randomized study was conducted on 40 healthy volunteers, with a diversity of gender, ethnicity and BMI. The main objective has been achieved. The aim was to evaluate the relative bioavailability of midazolam after injection with the Zeneo needleless auto-injector (10mg of midazolam in 0.625mL) compared to the injection of Dormicum (10mg of midazolam in 2mL) by conventional syringe with 30mm needle, in the thigh on bare skin. Bioequivalence was demonstrated on both Cmax and AUC, with no change in Tmax. The 90% confidence intervals of the Cmax and AUC ratios were respectively [84-98] and [100-108]. No serious adverse events were reported, and no differences in safety profile were found between the conditions tested. Only 2 subjects gave up before their fourth and last injection, not for safety reasons but for personal reasons.
As secondary objectives, the study aimed to test the intramuscular injection of midazolam with Zeneo into the thigh through clothing compared to the injection into the thigh on bare skin with Zeneo or with Dormicum. The 90% confidence intervals of the Cmax and AUC ratios were respectively [87-101] and [79-92] for the Cmax ratios, and [87-95] and [91-98] for AUC ratios with no change in Tmax. These results make it possible to envisage much faster emergency treatment, without having to remove the patient’s clothing in an epileptic seizure.
In addition, an intramuscular injection of Zeneo midazolam into the ventro-gluteal (ventrogluteal) site has been shown to be bioequivalent to an injection into the thigh on bare skin, either with a conventional syringe or with Zeneo.
Finally, Zeneo and the conventional syringe with intramuscular needle showed similar and low inter-subject variability in the pharmacokinetics of midazolam. This is further proof that an injection with Zeneo reaches the muscle in the same way as an injection with a 30mm needle syringe.
“In summary, the results of this clinical study are a great achievement for Crossject as they demonstrate the efficacy of intramuscular injection with the Zeneo needle-free auto-injector, on the thigh site with or without clothing, or on the ventro-gluteal muscle,” the group concludes.
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