Harm Reduction Therapeutics & Catalent Sign Commercial Supply Agreement for Naloxone Nasal Spray to Reverse Opioid Overdoses

Harm Reduction Therapeutics and Catalent recently announced the signing of a commercial supply agreement. Under its terms, Catalent will manufacture Harm Reduction Therapeutics’ naloxone nasal spray, RiVive (3 mg), for the emergency treatment of known or suspected opioid overdose.

The commercial supply agreement comes after the US 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 US opioid crisis. In anticipation of FDA approval in July 2023 and US launch in early 2024, Catalent will manufacture RiVive at its facility in Morrisville, NC.

“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, PhD, 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-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. It works alongside Catalent’s facility in Durham, NC, to support global customers with an extensive range of small molecule and biologic analytical services.

 Harm Reduction Therapeutics (HRT), Inc. is a 501(c)(3) non-profit pharmaceutical company whose mission is to prevent opioid overdose deaths by making free or low-cost over-the-counter naloxone available to everyone. Founded in 2017 in response to the severe price and access limits to existing naloxone products, HRT brings together experts in drug development, harm reduction, substance dependence, public health policy, and over-the-counter switches of prescription pharmaceuticals. For more information, visit www.harmreductiontherapeutics.org.

 Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.

Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply around 80 billion doses of nearly 8,000 products annually. Catalent’s expert workforce of approximately 18,000 includes more than 3,000 scientists and technicians. Headquartered in Somerset, NJ, the company generated nearly $5 billion in revenue in its 2022 fiscal year. For more information, visit www.catalent.com.