Rafa Laboratories was awarded a follow-on production agreement for a total value of over $45 million from the Defense Department's (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). Under this follow-on production agreement, Rafa has manufactured and began delivering 10mg Midazolam Injection autoinjectors to the Joint Force since December 2022.
The Midazolam Injection autoinjector is indicated for the treatment of status epilepticus in adults. As such, this new Advanced Anticonvulsant System (AAS) autoinjector can be used to treat seizures resulting from nerve agent exposure. According to JPEO-CBRND, "the AAS improves upon, and will eventually replace, the currently fielded Convulsant Antidote for Nerve Agent (CANA) diazepam autoinjector. Fielding the Midazolam Injection autoinjector gives the warfighter and the Nation access to a life-saving medical countermeasure in CBRN environments."
This production agreement is a follow-on to a prototype other transaction agreement (W911QY2090014) between the two parties that led to U.S. Food and Drug Administration (FDA) approval of the Midazolam Injection autoinjector on 2022.
According to guidelines of the American Epilepsy Society, Midazolam Intramuscular is a first-line therapy for Status Epilepticus.
Rafa's innovation resides in the use of an autoinjector to be administered intramuscularly to the thigh (can be administered through clothes as well), in a simple and fast manner which does not require an intravenous line. This is a significant advantage in a field setting during an emergency, when fast treatment reduces the likelihood of permanent damage that could result from a continuous seizure.
The product was developed and is currently being manufactured at Rafa's site located in Jerusalem, Israel. It is already sold for emergency purposes to NATO member states and is an important addition to Rafa's expanding autoinjector portfolio, which includes various formulations for emergency use.
