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Harm Reduction Therapeutics and Catalent have signed a commercial supply agreement for naloxone nasal spray to reverse opioid overdoses.
Harm Reduction Therapeutics, a non-profit pharmaceutical company focused on preventing opioid overdose deaths, and Catalent announced on March 23, 2023 that they have signed a commercial supply agreement. Under the agreement, Catalent will manufacture Harm Reduction Therapeutics’ naloxone nasal spray, RiVive, for the emergency treatment of known or suspected opioid overdose.
The agreement comes after FDA granted Harm Reduction Therapeutics priority review status on Dec. 26, 2022, for its over-the-counter (OTC) naloxone nasal spray new drug application. Naloxone has been used extensively for decades to reverse opioid overdoses, according to a company press release. Access to existing naloxone nasal spray is currently limited to behind-the-counter pharmacy distribution through a prescriber or a health department’s standing order.
Harm Reduction Therapeutics has been working on a low-cose, OTC naloxone product since 2017 to act as a critical tool to help prevent death from opioid overdose.
“We are thrilled to partner with Catalent 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,” said Michael Hufford, co-founder and CEO of Harm Reduction Therapeutics, in the release.
“This agreement marks a major milestone for Harm Reduction Therapeutics and is also a significant step forward in tackling a major public health issue in this country,” said Carla Vozone, vice-president of inhalation strategy at Catalent, in the release. “Our company is driven by a ‘patient-first’ culture, which is synergistic with the goals and mission of our partner on this project, and we take great pride in being associated with such a potentially life-changing program.”