- Opiant Pharmaceuticals has snagged a multi-year federal contract to push forward development of a long-acting opioid reversal agent that a U.S. government agency believes could be useful in counteracting a potential terrorist attack that uses weaponized opioids, the Department of Health and Human Services announced Thursday.
- While the specialty pharmaceutical company has previously focused on people misusing painkillers, the Biomedical Advanced Research and Development Authority, or BARDA, sees the potential of OPTN003, a nasal formulation of opioid antagonist nalmefene, as a defense against hostile use of the drug.
- The BARDA contract could be worth up to $4.6 million. Opiant already received a $7.4 million grant from the National Institute on Drug Abuse.
Opioid misuse, addiction and accidental overdose has been declared an U.S. national health emergency for nearly a year. BARDA, though, focuses on the domestic security implications of opioids, and synthetic opioids such as fentanyl have been used not just as a drug of abuse but as a weapon.
In the early 2000s, for example, Russian forces used fentanyl vapor to end a hostage standoff with Chechen rebels, resulting in 117 deaths and many more people hospitalized.
The Food and Drug Administration, meanwhile, has expanded the distribution of priority review vouchers to cover the development of material threat medical countermeasures, including diagnostics, therapeutics and prophylactics for conditions linked with chemical, biological, radiological and nuclear threats. The vouchers cut four months off the standard 10-month review timeline.
These recent federal contracts will allow Opiant to explore its drug candidate’s potential in the broader stage of national security.
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“This $4.6 million BARDA contract, combined with the recently awarded $7.4 million grant we received from the National Institute on Drug Abuse, further validates the potential of nasal nalmefene to be a vital life-saving product, both to reverse opioid overdose and to counter bioterrorism attacks,” Opiant CEO Roger Crystal said.
Naloxone is the most commonly used treatment for opioid overdose in the U.S., although it has a short half-life, and so may require repeat dosing. Nalmefene has a fast onset and longer duration of action, but was previously only available in its injected form. Due to low uptake, previous manufacturers discontinued marketing of the drug in 2008.
OPTN003 combines the longer half-life of naloxone with the ease of use of a nasal spray.
“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 director Rick Bright said in a statement.
Opiant expects to begin a pivotal pharmacokinetic study for OPNT003 for FDA approval in 2019.
Date: September 24, 2018
Source: BiopharmaDive
