CMC Pharmaceuticals has secured grant funding from the US government to develop an easier-to-use treatment of chemical warfare agents such as sarin. The grant covers work on a concentrated formulation of atropine intended for use in the treatment of poisoning with organophosphates, a class of organic compounds that includes highly toxic, hard-to-treat nerve agents such as sarin.
Intramuscular injections of the anticholinergic atropine, known as ATNAAs or Antidote Treatment Nerve Agent Autoinjectors, are already used to treat military personnel who are exposed to nerve agents. However, three ATNAAs are needed to treat severe signs of nerve agent exposure and, in some cases, the treating physician could need to use 13 vials in 24 hours. CMC thinks it can develop a better option.
“A concentrated formulation will ease the administration of large amounts of atropine. A multi-dose vial containing a higher concentration of atropine sulfate would significantly decrease the logistical burden associated with having to use multiple vials to treat a single nerve agent casualty by simplifying dosing and decreasing material costs, medical wastes, and storage needs,” said a spokesperson for CMC.
The Department of Defense (DoD) put out a call for applications for funding to develop concentrated atropine sulfate formulations last year. The call for applications focused on “formulations of sufficient concentration to make dosing 2 mg atropine bolus injections easy.”
As the DoD sees things, developing higher-concentration, multi-dose vials “would significantly decrease the logistical burden associated with having to use multiple vials to treat a single nerve agent casualty, thereby simplifying dosing, and decreasing material costs, medical waste, and storage needs.”
The DoD request envisaged a three-phase project, starting with the demonstration of the feasibility of a concentrated atropine formulation and culminating in the development of scale-up processes and a tech transfer protocol for pilot lab and good manufacturing practice production.
CMC plans to run studies to support FDA approval of the drug with a view to selling it for inclusion in the national strategic stockpile. The provider of drug product development services and manufacturing support thinks it is well equipped to handle the work.
“The scientists at CMC have decades of relevant industry experience and are experts in drug product development. Our significant experience in developing injectable drug products applies directly to this Concentrated Atropine Formulation. Our lab and pilot plant allow us to perform all necessary studies onsite and prepare injectable formulation prototypes,” said the CMC spokesperson.