Catalent and Harm Reduction Therapeutics (HRT) announced that they have signed a commercial supply agreement for the manufacture of HRT’s RiVive intranasal naloxone. The news comes shortly after HRT said that it would receive an additional $9 million in funding from Purdue Pharma that would be used to prepare for possible commercialization of RiVive.
The FDA accepted HRT’s NDA for RiVive in December 2022 and set the goal date for completing its review of the application as April 28, 2023. According to the new announcement, if approved at that time, RiVive will be manufactured at Catalent’s facility in Morrisville, NC, USA for an expected launch in early 2024. Catalent completed a major expansion of the Morrisville facility’s nasal spray manufacturing capabilities in 2022.
HRT CEO Michael Hufford said, “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.”
Catalent VP of Inhalation Strategy Carla Vozone commented, “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. 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.”
Read the Catalent press release.
