Rafa has obtained the Food and Drug Administration’s clearance for its 10 mg midazolam auto-injector for the treatment of status epilepticus in adults.
The Midazolam 10 mg auto-injector is indicated for the treatment of status epilepticus, or prolonged seizures, in adults. As such, this new auto-injector can be used to treat seizures resulting from nerve agent exposure. According to the U.S. JPEO-CBRND, the auto-injector will replace the currently fielded convulsant antidote for the nerve agent diazepam autoinjector.
Rafa’s innovation resides in the use of an auto-injector to be administered intramuscularly to the thigh (can be administered through clothes as well), in a manner that 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 company said.
“We are proud of the FDA approval for this lifesaving product,” said Amir Levin, CEO of Rafa. “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.”
The product is made at Rafa’s manufacturing site in Jerusalem and is already sold under EUA in other territories.
“The usability of the auto-injector has a significant medical advantage in its immediate treatment effect, as well as in reducing long-term damage,” said Roy Shay, head of emergency solutions at Rafa. “Clinical studies confirmed the correlation between early treatment of status epilepticus and a reduced risk of an ongoing and irreversible neurological damage. This product could assist in saving many lives around the globe.”