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BARDA and Rafa Laboratories  Developing Pediatric Atropine Autoinjectors

As part of ongoing United States national preparedness efforts for emergencies involving nerve agents, the Biomedical Advanced Research and Development Authority (BARDA) is collaborating with Rafa Laboratories LTD to develop an improved version of the company’s prefilled atropine autoinjector to treat nerve agent and insecticide poisoning in pediatric populations. The mission of BARDA is to develop and procure medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) incidents; pandemic influenza, and emerging infectious diseases.

Nerve agents (such as sarin, VX, etc.) and other organophosphates (including some insecticides) are highly poisonous chemicals that can prevent the nervous system from functioning properly, resulting in seizures, respiratory failure, coma, and potentially death. Rapidly delivering effective medical countermeasures following a nerve agent incident is critical to saving lives, particularly during emergencies involving large numbers of people. In general, autoinjectors can be used rapidly and easily by emergency personnel to administer medication to patients. Atropine is the primary antidote in nerve agents and insecticide poisoning and is typically administered using an autoinjector.

Having U.S. Food and Drug Administration (FDA) approved products readily available during a disaster can help to save lives and increase preparedness by streamlining and simplifying the emergency response. Currently, Rafa manufactures adult atropine autoinjectors, which were FDA-approved in July 2018, as well as pediatric atropine autoinjectors, which were authorized for use through FDA Emergency Use Authorization (EUA) in January 2018 to treat nerve agent and insecticide poisoning.

While Rafa’s atropine autoinjectors are already in use in military settings, the design is not ideal for civilian responses. The current autoinjector platform leaves the needle exposed post-activation, which enables responders to bend the needle into a hook shape and pin it to the clothing of the treated person; this approach allows medical personnel to quickly and easily determine the number and dose of atropine administered. However, the exposed needle complicates the disposal of the autoinjector and increases the likelihood of injuries to first responders. The design of the improved pediatric atropine autoinjector will include a needle shield element to prevent potential needle stick injuries, thereby enabling a safer response to a civilian public health emergency involving nerve agents.

BARDA will provide support to Rafa for advanced development activities and human factor studies, as well as all associated regulatory, quality assurance, management, and administrative activities necessary to meet requirements for FDA approval of the improved pediatric atropine autoinjector with a post-injection needle protection platform mechanism. The pediatric atropine autoinjectors will be developed in two dosage strengths, which will be used based on patient weight.

If successful, the improved Rafa pediatric autoinjector platform could enable additional support for advanced development activities and submission for FDA approval of the adult atropine and midazolam autoinjectors with the new needle protection mechanism. The new device also is expected to meet the FDA’s requirement for 99.999% reliability for emergency use autoinjectors.

This award is a continuation of BARDA’s commitment to the development of pediatric medical countermeasures, as highlighted in the BARDA 2022-2026 Strategic Plan. The plan emphasizes the importance of supporting medical countermeasures that protect all members of our communities against an evolving threat landscape, including pediatric and at-risk populations. This new autoinjector platform can help enhance the nation’s health security by providing a safer and more effective way to administer life-saving medical countermeasures for children.

About Rafa

Founded in 1937 and headquartered in Jerusalem, Israel, Rafa is among the leading pharmaceutical companies in Israel and a global player in emergency solutions – medical countermeasures, supplying auto-injectors for government agencies, military forces, and civilian populations. Rafa‘s competencies span the entire value chain from R&D and manufacturing by international standards (e.g. FDA, EMA) through sales and marketing. With a proven track record of successful commercialization of niche and orphan products, Rafa has been privileged to nurture long-lasting alliances with leading innovative companies such as United Therapeutics, Helsinn, Zambon, Galderma, Dr. Falk, and Mundipharma, in a variety of therapeutic areas including oncology, hematology, respiratory, gastroenterology, and dermatology. Rafa‘s controlling shareholder, FIMI Opportunity Funds, is the leading private equity fund in Israel with a track record of success spanning over 25 years and assets under management of $7b. Since its inception, FIMI’s performance has been exceptional by both local and global standards after having completed close to 100 investments.

For additional information, please contact:
Roy Shay, Head of Emergency Solutions at Rafaroys AT

Source:  Medical

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