Crossject announces publication of clinical data on ZEPIZURE® in Neurology and Therapy
Clinical study performed in 2022 now published in peer-reviewed Neurology and Therapy Further elaborates on bioequivalence demonstrated versus European listed drug Dormicum® Early onset can be expected thanks to early blood concentration of midazolam with ZEPIZURE® Low variability confirmed, a key advantage vs other forms of administration, such as intranasal
Dijon, France May 30, 2024 -1030 am CET- Crossject (ISIN: FR0011716265; Euronext: ALCJ), a specialty pharma company in advanced phases of development and registration for ZEPIZURE®, its emergency treatment for the management of epileptic crises based on its award-winning needle-free auto- injector ZENEO®, announces the publication of clinical data in the peer-reviewed journal Neurology and Therapy.
Seizures require urgent treatment when they last longer than 5 minutes and when prolonged, can lead to damage to the brain, coma, and ultimately death. Midazolam injected in the muscle has become the first-line treatment of choice for long-lasting seizures. ZEPIZURE®, based on the ZENEO® autoinjector and previously known as ZENEO® Midazolam, provides for needle-free delivery of midazolam with significant associated advantages.
The article now published outlines full results of a clinical study conducted in 2022, demonstrating that ZENEO® allows injecting midazolam intramuscularly, on bare skin or through clothing, to the same extent as a syringe equipped with a 30mm needle (Dormicum®), and with a 2-fold lower variability as compared to that usually observed for routes of administration such as intranasal. In addition, ZEPIZURE® enhanced the midazolam absorption during the first minutes post-injection, suggesting that seizure treatment may be efficient sooner. The safety profile, level of pain and sedation were comparable to intramuscular syringe injection. The maximum blood concentration reached with ZEPIZURE® is not above that with Dormicum®, which is a good indication in terms of safety.
“The ZENEO® needle-free auto-injector is an innovative, prefilled, single-dose, ready-to-use, two-step device that could become the best in-class device for midazolam intramuscular administration in emergencies. Delivery of the full, 10mg dose in a safe manner, with low variability and in convenient conditions, is a decisive advantage in emergency situations,” said Olivier Lacombe, PhD, Director Pharmaceutical Development of Crossject and lead author of the article.