September 20, 2018
HHS Sponsors Development of Intranasal Form of Long-acting Opioid Overdose Drug
To help save lives in the current opioid epidemic or following a deliberate attack, the U.S. Department of Health and Human Services (HHS) will work with Opiant Pharmaceuticals of Santa Monica, California, to develop a fast-acting, long-lasting intranasal, potentially improved form of an opioid overdose drug.
“The life-saving drug naloxone, while effective, often must be given multiple times to completely reverse the effects of an opioid in someone exposed to high doses. Repeat doses of the treatment may not always be feasible, especially in a large-scale terrorist attack,” said Rick Bright, Ph.D., director of the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response. “Improved opioid exposure treatments are critical to adequately address this growing threat to public health and health security.”
BARDA will partner with Opiant to develop a new formulation of the drug, called nalmefene. Synthetic opioids like fentanyl and its derivatives are now the most common cause of overdose deaths in the United States. The potential for weaponization of these agents is also a concern.
Naloxone is the most commonly used treatment for opioid overdose in the United States. Because of the shorter half-life of naloxone compared to fentanyl derivatives, repeat dosing of naloxone often is needed to fully reverse the effects of the opioid. Longer lasting drugs can reduce the need for repeat dosing. Nalmefene acts in the same way as naloxone and studies suggest that it may work for much longer.
Under a one-year, approximately $611,000 contract with BARDA, Opiant will advance the development of intranasal nalmefene, using a proprietary absorption enhancer, to treat confirmed or suspected opioid overdoses. The contract can be extended up to a total of $4.6 million over three years for work necessary to apply for U.S. Food and Drug Administration approval.
In addition, the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, provided a grant earlier this year for Opiant to perform formulation development and clinical studies for this product and funded an initial clinical study that showed the new additive given with nalmefene and administered intranasally to be as active as the injected form. BARDA and NIDA will be coordinating on the development of this treatment.
Injection nalmefene is approved by the FDA for opioid overdoses, but the drug was removed from the U.S. market in 2008 due to low sales and is no longer available. Returning nalmefene to market in an easy-to-administer intranasal formulation may be an important addition to the nation’s preparedness for current and emerging opioid threats.
BARDA continues to seek proposals for development of effective products to treat injuries caused by chemical agents, including new products or new indications for products already in clinical use. These products must be easy to use in a mass casualty situation and safe and effective for all segments of the population. Proposals are accepted through the Broad Agency Announcement BAA-18-100-SOL-00003 at the Federal Business Opportunities website, www.fbo.gov.
About HHS, ASPR and BARDA
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of the Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats.
For more about ASPR and BARDA, visit www.phe.gov/aspr. To learn more about partnering with BARDA on advanced development of medical countermeasures – drugs, vaccines and devices for emergencies – visit www.medicalcountermeasures.gov.