BARDA and Crossject partner under Project BioShield to provide novel needle-free ZENEO Midazolam autoinjectors for national preparedness


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Nerve agents such as sarin, VX, and other organophosphates are highly poisonous chemicals that can prevent the nervous system from functioning properly, resulting in seizures, respiratory failure, coma, and potentially death. Rapidly delivering effective medical countermeasures following a nerve agent incident is critical to saving lives, particularly during emergencies involving large numbers of people.

As part of ongoing national preparedness efforts for emergencies involving nerve agents, BARDA will use Project BioShield Act authority and funding to work with Crossject of Dijon, France, to develop and procure ZENEO needle-free autoinjectors containing midazolam, an anticonvulsant, to treat nerve agent exposure. These autoinjectors would become part of the CHEMPACK program 

The CHEMPACK program represents a comprehensive capability to store and distribute medical countermeasures effectively to treat civilians rapidly following an incident involving nerve agents. To enable first responders to administer life-saving aid easily during a chemical incident such as a nerve agent exposure, containers of nerve agent antidotes called CHEMPACKs are placed in secure locations in local jurisdictions around the country.

Since 2004, Project BioShield Act authority and funding have helped to accelerate the research, development, purchase, and availability of effective medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) threats. Having U.S. Food and Drug Administration (FDA)-approved products readily available during a disaster can save lives and increase preparedness by streamlining and simplifying the emergency response. In 2018, BARDA supported the development and approval of Seizalam (midazolam vials for intramuscular injection); the product was approved by the FDA for the treatment of status epilepticus seizures in adults, including seizures resulting from nerve agent exposure. 

The 2007 U.S. Department of Health and Human Services (HHS) Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Implementation Plan for CBRN Threats called for updating the CHEMPACK program with improved medical countermeasures, such as anticonvulsants, as they became available. Since midazolam is already FDA-approved, and a more efficacious seizure treatment than the current diazepam treatment, the acquisition and approval of pediatric and adult midazolam autoinjectors would fulfill this PHEMCE requirement. 

BARDA will provide funding to Crossject to carry out advanced research studies and late-stage clinical development with the goal of obtaining full regulatory approval for ZENEO Midazolam autoinjectors (as a drug/device combination product). Procurement of ZENEO Midazolam autoinjectors will start as soon as the product receives FDA emergency use authorization (EUA); Crossject will seek full FDA approval for both adult and pediatric populations. In addition to developing ZENEO Midazolam for adult populations, this contract also supports the development of a pediatric dose autoinjector, which will enhance U.S. capabilities to treat children effectively in an emergency involving nerve agent exposure.

In general, autoinjectors can be used rapidly and easily by emergency personnel including first responders to administer medications to patients. This contract supports the development and evaluation of autoinjectors for midazolam that are intuitive and can be used easily by first responders who are wearing protective HazMat gear, which potentially hinders the users’ vision or dexterity. Additionally, having needle-free autoinjectors available in adult and pediatric dosages would provide a significantly enhanced capability to the CHEMPACK program. Needle-free devices help simplify emergency response and protect patients and first responders by reducing the danger of cross-contamination and eliminating the risk of needle-stick injuries and the need for sharps disposal. The new Crossject device also is expected to meet the FDA’s requirement for 99.999% reliability for emergency use autoinjectors. 

This partnership provides the government with the opportunity to develop, acquire, stockpile, and make available the medical countermeasures needed to fortify the nation’s health security and protect the U.S. population against nerve agents.

About CROSSJECT:

The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.

Crossject (ISIN: FR0011716265; Ticker: ALCJ; LEI: 969500W1VTFNL2D85A65) is developing and is soon to market a portfolio of drugs dedicated to emergency situations: epilepsy, adrenal crisis, allergic shock, overdose, asthma attack, severe migraine. Thanks to its patented needle-free self-injection system, Crossject aims to become a world leader in self-administered emergency drugs. The Company has been listed on Euronext Growth Paris since 2014, and benefits from Bpifrance funding.

Last Updated: June 30, 2022

CBRN Portfolio

The CBRN investments support advanced research and development and national security procurement of medical countermeasures to addresses national security threats. This award is one component of BARDA's CBRN medical countermeasure portfolio; visit the CBRN Portfolio to learn more.