Harm Reduction Therapeutics, a 501(c)(3) non-profit pharmaceutical company whose mission is to prevent opioid overdose deaths, signed a commercial supply agreement with Catalent for the manufacture of Harm Reduction Therapeutics’ naloxone nasal spray, RiVive (3.0 mg), for the emergency treatment of known or suspected opioid overdose.
 
The commercial supply agreement comes after the U.S. FDA granted Priority Review status on December 26, 2022, for the over-the-counter (OTC) naloxone nasal spray NDA. Naloxone is a safe and effective opioid antagonist, having originally been approved by the FDA in 1971 and has been used extensively to reverse opioid overdoses. Access to existing naloxone nasal sprays is currently limited to behind-the-counter pharmacy distribution through a prescriber or a Health Department’s standing order.
 
In anticipation of FDA approval in July 2023 and U.S. launch in early 2024, Catalent will manufacture RiVive at its facility in Morrisville, NC.
 
Catalent’s 180,000 sq.-ft. inhalation development facility in Morrisville includes development and manufacturing for unit-dose, bi-dose and preserved multi-dose nasal sprays, as well as comprehensive spray testing capabilities. 
 
“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, Ph.D., Co-Founder and Chief Executive Officer of Harm Reduction Therapeutics.
 
“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. “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.”