Under today’s five-year, $60 million contract, Meridian Medical Technologies Inc. of Columbia, Md., a Pfizer company, will conduct studies of midazolam to seek approval from the U.S. Food and Drug Administration for the drug’s use in treating seizures caused by nerve agents. Meridian also will seek FDA approval of a midazolam autoinjector for children and adults, and seek approval of midazolam for use in treating common prolonged seizures.
Midazolam is approved as a fast-acting, highly effective pre-operative sedative for adults and children. Although not approved for treatment of seizures, the drug also may stop prolonged seizures including those caused by nerve agents. Nerve agents attack the nervous system by blocking an enzyme required for the proper control of nerve impulses, leading to the continual transmission of those impulses. In the brain, the result of this process is convulsions or seizures.
To prevent convulsions or seizures, anticonvulsant medications make brain cells resistant to this
An autoinjector, a hypodermic syringe used to inject a patient with a premeasured single dose of medication, is used commonly to administer insulin for diabetes and lifesaving medication for allergic reactions such as bee stings. The nerve agent anticonvulsant currently in the Strategic National Stockpile for emergency use can only be administered to children using multi-dose vials, which is more time-consuming than using autoinjectors.
The work supported by this contract builds on Meridian’s participation in a large study in which midazolam was used to treat prolonged seizures. The study indicated that as an anticonvulsant for common prolonged seizures midazolam works faster, is easier to inject, and hurts less at the injection site than the anticonvulsant currently in the stockpile to treat seizures caused by nerve agents.
Data from this and other studies could support FDA in authorizing emergency use of midazolam in a chemical weapons attack prior to the drug’s approval. The contract includes purchase of midazolam in autoinjectors for adults and multi-dose vials for adults and children for emergency use while the company conducts the additional studies.
“Midazolam is the eleventh product to be developed or purchased through Project BioShield in less than 10 years, so we’re making unprecedented progress in becoming a more prepared nation, which is critical, especially in light of current chemical threats,” said Robin Robinson, Ph.D., director of ASPR’s Biomedical Advanced Research and Development Authority, which oversees the program. “The repurposing of existing drugs like midazolam shows the flexibility of Project BioShield and the strength of the federal government’s enterprise approach to developing products that protect health from chemical and bioterrorism weapons.”
Project BioShield is the chief mechanism through which the U.S. government supports the advanced development and procurement of new medical countermeasures - drugs, vaccines, diagnostics, and medical supplies - to protect health against chemical, biological, radiological and nuclear threats.
Under the Project BioShield Act of 2004, BARDA has supported the development and procurement of two anthrax antitoxins to treat people with anthrax disease and an anthrax vaccine, as well as drugs or medical products to protect health against smallpox, botulism, and radiation injury.
BARDA, within the HHS Office of the Assistant Secretary for Preparedness and Response, provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. The Office of the Assistant Secretary for Preparedness and Response (ASPR) is an HHS leader in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.