FDA approves ‘first-in-market’ autoinjector for treating prolonged seizures.
Rafa Laboratories announced today that it received FDA approval for its 10mg Midazolam autoinjector for treating status epilepticus, or prolonged seizures.
Jerusalem-based Rafa developed the autoinjector through cooperation with the U.S. Department of Defense’s (D0D) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND).
Rafa’s Midazolam 10mg autoinjector received FDA indication for the treatment of status epilepticus in adults.
This means the new autoinjector can be used to treat seizures resulting from nerve agent exposure. JPEO-CBRND determined that the autoinjector improves upon and will replace the currently fielded convulsant antidote for nerve agent (CANA), the diazepam autoinjector.
The autoinjector is administered intra-muscularly to the thigh in a simple and fast manner that does not require an intravenous line. It can be administered through clothes. These are significant advantages in a field setting during an emergency when fast treatment reduces the likelihood of permanent damage that could result from a continuous seizure, Rafa said in a news release.
“The usability of the autoinjector has a significant medical advantage in its immediate treatment effect, as well as in reducing long-term damage,” Rafa Head of Emergency Solutions Roy Shay said in the release. “Clinical studies confirmed the correlation between early treatment of status epilepticus and a reduced risk of ongoing and irreversible neurological damage. This product could assist in saving many lives around the globe.”
Rafa and DoD previously collaborated on the development of Rafa’s Atropine autoinjector which was launched in the U.S. in 2017. The DOD’s Chemical and Biological Defense Program also supported this effort.
Rafa said FDA approval followed an expedited review. The product was developed in Israel and is manufactured at Rafa’s site in Jerusalem. It is already sold under emergency use authorization in other territories.
“We are proud of the FDA approval for this life-saving product,” added Rafa CEO Amir Levin. “It is made in Israel and is meaningful news to the world of medical emergency solutions, thus strengthening Rafa’s key role in providing reliable products to armies, governments, and first responders worldwide.”