Somerset-based Catalent has signed a commercial supply agreement with Harm Reduction Therapeutics of Pittsburgh, PA, to manufacture the latter company’s naloxone nasal spray, RiVive™ (3.0 mg), for the emergency treatment of known or suspected opioid overdose.
The agreement comes after the U.S. Food and Drug Administration (FDA) granted Harm Reduction Therapeutics Priority Review status on December 26, 2022, for its over-the-counter (OTC) naloxone nasal spray New Drug Application. Naloxone is a safe and effective opioid antagonist, having originally been approved by the FDA in 1971 and has been used extensively for decades by both medical professionals and the lay public to successfully 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.
Since 2017, Harm Reduction Therapeutics has been working on a low-cost, OTC naloxone product to act as a critical tool to help stem the loss of life from the U.S. opioid crisis. In anticipation of FDA approval in July 2023 and U.S. launch in early 2024, Catalent will manufacture RiVive at its facility in Morrisville, North Carolina.
“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.”
Catalent’s 180,000 square-foot 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. It works alongside Catalent’s facility in Durham, North Carolina, to support global customers with an extensive range of small molecule and biologic analytical services.
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