BARDA is part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response.
OPTN003, nasal nalmefene, is a potent, long-acting opioid antagonist currently in development for the treatment of opioid overdose.
Opioid overdose is a significant public health crisis worsened by the increasing prevalence of synthetic opioids, such as fentanyl. Fentanyl is 50-fold more potent than heroin, far easier and less expensive to produce and has a significantly longer half-life. Fentanyl and related synthetic opioids were linked to more than 55% of the nearly 49,000 opioid overdose deaths in 2017 in the U.S.
In the early 2000s, fentanyl vapor was used by Russian forces to end a hostage standoff with Chechen rebels, resulting in 117 deaths and hundreds more hospitalized, illustrating the potential for weaponizing synthetic opioids.
The contract with BARDA will allow for accelerated development of OPNT003 as a medical countermeasure in the event of a fentanyl chemical attack. The high affinity of nalmefene at mu opioid receptors, combined with a rapid onset of action and long duration of action, makes it particularly well-suited to treat fentanyl overdose.
BARDA director Dr Rick Bright said: “Current treatments sometimes require multiple doses to be effective and in a large-scale terrorist attack involving fentanyl or similar drugs, repeat doses of the treatment may not always be feasible.
“BARDA is committed to developing opioid exposure treatments to protect public health and our nation’s health security.”
Opiant. CEO Dr Roger Crystal said: “Our approach to drug development is driven by innovative thinking and a commitment to public-private collaboration.
“This $4.6 million BARDA contract, combined with the recently awarded $7.4 million grant we received from the National Institute on Drug Abuse (NIDA), further validates the potential of nasal nalmefene to be a vital life-saving product, both to reverse opioid overdose and to counter bioterrorism attacks.
“We expect to begin the pivotal pharmacokinetic study required for approval of OPNT003 by the U.S. Food and Drug Administration in 2019.”
The BARDA contract will cover activities not funded by the NIDA grant through a potential New Drug Application submission, and provides approximately $611,000 for the project from now through September 30, 2019, with the balance to be funded over the subsequent two years, subject to satisfactory project progress, funds availability and certain other conditions.
Source: Company Press Release