• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

FDA approves ‘first-in-market’ autoinjector for treating prolonged seizures

August 30, 2022 By Sean Whooley

Rafa Laboratories Midzolam autoinjector
[Image from Rafa]
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.”

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Neurological, Pharmaceuticals, Regulatory/Compliance Tagged With: FDA, Rafa Laboratories

IN CASE YOU MISSED IT

  • Insulet hires new chief HR officer from J&J
  • Breakthrough T1D, Mattel debut Barbie doll with type 1 diabetes
  • Medtronic Diabetes names CFO with consumer experience ahead of separation
  • Diabeloop launches insulin delivery algorithm in Germany
  • GlucoModicum has positive data for needle-free CGM

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS