Harm Reduction Therapeutics announced that it has signed a commercial supply agreement for its RiVive (HRT001) intranasal naloxone after the FDA granted Fast Track designation to the nasal spray, which is in development as a low cost OTC product for the reversal of opioid overdose. HRT did not name the company it contracted with but said that RiVive would be manufactured at a US facility.
Harm Reduction is a non-profit company founded in 2017, and the naloxone nasal spray is the sole product in its pipeline. OxyContin maker Purdue Pharma began funding the project in 2018 and, earlier this year, the company got an additional $11 million for development of the nasal spray from Purdue.
HRT CEO Michael Hufford said, “This commercial supply agreement and the FDA’s Fast Track designation mark major milestones for Harm Reduction Therapeutics and are significant steps forward in making OTC naloxone a reality.”
Chief Operating Officer Bernie Simone added, “We are thrilled to partner with our contract manufacturer on the commercial manufacturing of RiVive. The opioid epidemic is an ongoing national tragedy, and for OTC naloxone to address this unmet need we needed a manufacturing partner with the capability and bandwidth to help make naloxone much more widely and easily accessible to save lives that will otherwise be lost to opioid overdose.”
Read the Harm Reduction Therapeutics press release.
