Israeli company gets FDA approval for seizure-treating injector

Manufactured in Jerusalem, the EpiPen-style autoinjector is meant to treat prolonged seizures in adults exposed to nerve agents. 

 Rafa factory in Jerusalem  (photo credit: Courtesy)
Rafa factory in Jerusalem
(photo credit: Courtesy)

Israeli medical company Rafa Laboratories received FDA approval for their 10 mg midazolam autoinjector, which can treat seizures caused by nerve agent exposure, the company announced Tuesday.

The project, part of a cooperation between Rafa and the US Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), is meant to treat status epilepticus – otherwise known as prolonged seizures – in adults exposed to nerve agents. 

The JPEO-CBRND, who collaborated with Rafa on Rafa’s Atropine autoinjector that was launched in the US in 2017 to treat victims of poisoning, said the new injector will replace the currently fielded convulsant antidote for nerve agent (CANA) diazepam autoinjector.

Manufactured in Jerusalem, the injector can be applied to the muscles (intra-muscularly) – making it the first injector for seizures that do not require application via an intravenous line.

“The usability of the autoinjector 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. “This product could assist in saving many lives around the globe,” he declared.

 Rafa Laboratories LTD's 'Midzolam Injection.'' (credit: Courtesy) Rafa Laboratories LTD's 'Midzolam Injection.'' (credit: Courtesy)

What is Rafa and what do they do?

Founded in 1937 and headquartered in Jerusalem, Israel, Rafa is among the leading pharmaceutical companies in Israel and a global player in emergency solutions – such as medical devices for government agencies, military forces and civilian populations. 

A vertically-integrated innovator in their field, Rafa has worked with leading innovative companies such as United Therapeutics, Helsinn, Zambon, Galderma, Dr. Falk and Mundipharma. Rafa’s experience also spans a variety of therapeutic areas – including oncology, hematology, respiratory, gastroenterology, and dermatology.