Public Health Emergency - Leading a Nation Prepared
Author: Judith Laney, Ph.D., Chief, BARDA Chemical Medical Countermeasures programs, and LTC Matthew Clark, Ph.D., Joint Product Manager, Chemical Defense Pharmaceuticals, Medical Countermeasure Systems Published Date: 10/31/2018 10:35:00 AM
Category: Medical Countermeasures;
With the recent U.S. Food and Drug Administration approval of the drug Seizalam® (midazolam injection) as an anti-seizure medication, the United States took a step forward in protecting Americans from a potentially deadly health effect of chemical weapons.
Over the last 25 years, there has been increased use of chemical weapons. Delivering effective medical countermeasures against nerve agents is essential to saving civilians’ lives in the United States, and is necessary to ensure that the Joint Force maintains mission effectiveness to protect the nation.
Having this drug, developed by Meridian Medical Technologies, available in multi-use vials makes drug administration easier in emergencies involving a large number of people exposed to chemicals that cause prolonged seizures, whether those situations are in combat, domestic accidents or an intentional attack in the United States.
Midazolam originally was approved by FDA for use as a sedative. This recent FDA approval of intramuscular midazolam (trade name, Seizalam) expands the possible uses of the drug, enabling it to be used to treat status epilepticus in civilian and military hospitals, as well as in combat casualty care. Expanding the indication of midazolam provides greater utility to civilian and military communities.
Status epilepticus involves a seizure that lasts longer than five minutes or multiple seizures within five minutes, without returning to a normal level of consciousness between seizures. Status epilepticus can lead to permanent brain damage or death. Nerve agents and organophosphorus pesticides as well as other conditions can cause these types of seizures.
Reaching this milestone is also the story of a successful public-private partnership. HHS and DoD offices worked closely with the company to earn this approval. Following early research by the U.S. Army Medical Research Institute of Chemical Defense and the National Institutes of Health, the U.S. Army Joint Project Management Office for Medical Countermeasure Systems (JPM-MCS)and the Biomedical Advanced Research and Development Authority (BARDA) worked closely with Meridian Medical Technologies, a Pfizer company, to develop the drug as an anticonvulsant.
The data necessary for the FDA consider approval came from a large HHS-funded clinical study, called RAMPART, which leveraged an NIH grant, BARDA’s Project BioShield funding, and autoinjectors provided by JPM-MCS. Under Project BioShield BARDA also funded follow-on work necessary for Meridian to apply for the FDA approval.
The JPM-MCS is capitalizing further on the RAMPART study to finish development and approval of its midazolam autoinjector medical countermeasure. This type of autoinjector device would make the drug easier to use on the battlefield, providing more immediate relief to U.S. and allied troops. The autoinjector would also function as part of a suite of medical products that serve as first-line-of-defense medical treatments for U.S. troops against chemical warfare agents and for emergency responders in the United States.
The JPM-MCS has worked closely with Meridian over the last 10 years to develop the drug-device combination product. The recent FDA approval may help the company, and the Army, to accelerate the process to apply for full FDA approval of the midazolam autoinjector in the coming years. By leveraging the RAMPART study, JPM-MCS expects to save approximately $30 million and reduce the time to apply for FDA approval by at least three years.
Now that FDA has approved the drug for use in treating seizures, BARDA has purchased 675,000 multi-dose vials for the Strategic National Stockpile, and DOD plans to field the vialed midazolam for military hospitals in the coming months. If development is successful and FDA clears the device for use with midazolam, BARDA will be able to purchase the midazolam autoinjectors for the Strategic National Stockpile to replace the anti-seizure drug currently in the stockpile’s CHEMPACKs.
Including this latest midazolam FDA approval, BARDA-sponsored medical countermeasures now have earned 42 FDA approvals, licenses, or clearances.
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