Harm Reduction Therapeutics (HRT), Inc., the 501(c)(3) nonprofit pharmaceutical company working to prevent opioid overdose deaths, has made an exciting breakthrough: the FDA has accepted their New Drug Application (NDA) for the OTC RiVive (3.0 mg intranasal naloxone) product and granted it Priority Review. This is a major milestone in the public health effort to make naloxone available to the public without a prescription. HRT is expecting to hear back from the FDA regarding the approval of RiVive by April 28, 2023.
The opioid epidemic is an ongoing national tragedy, claiming over 200 lives daily. In response, naloxone has remained a costly prescription-only product available on a state-by-state basis. But FDA’s recent preliminary assessment of certain naloxone products has opened the door to the possibility of over-the-counter use, and Harm Reduction Therapeutics is taking the lead with its OTC NDA for RiVive. This is a direct result of FDA’s call for pharmaceutical companies to bring forward OTC applications for naloxone and could be a game-changer in the fight against the opioid crisis.
Five years ago, Harm Reduction Therapeutics recognized the urgent need for an over-the-counter naloxone product, and took action where no other company had. Thanks to our success in pushing RiVive towards FDA approval, the public health landscape is transforming – and soon, OTC naloxone may become a reality. Dr. Michael Hufford, Co-Founder and Chief Executive Officer at Harm Reduction Therapeutics, is proud to have sparked this change.
Harm Reduction Therapeutics’ NDA is supported by promising data from a Phase 1 clinical trial, demonstrating that RiVive significantly increases systemic exposure compared to the reference naloxone product, as well as successful Human Factors Validation work that demonstrates laypeople are able to rapidly administer RiVive during an emergency overdose situation. With the anticipation of FDA approval, HRT has already secured a commercial supply agreement and is on track for a U.S. launch in early 2024.
About RiVive
RiVive is an innovative intranasal spray of naloxone (3.0 mg) for the reversal of opioid overdoses. Developed using a standard unit dose system, the atomized spray (0.1 ml) is a safe and effective way to administer this opioid antagonist, which has been used with success by medical professionals and lay public since its FDA approval in 1971.5,6
About Harm Reduction Therapeutics, Inc.
Harm Reduction Therapeutics (HRT), Inc. is a non-profit pharmaceutical company on a mission to prevent opioid overdose deaths by making naloxone accessible to everyone. Founded in 2017, HRT brings together experts in drug development, harm reduction, substance dependence, public health policy, and over-the-counter switches of prescription pharmaceuticals to make sure that naloxone is available free or at a low cost. With a vision of creating a world free of opioid overdose deaths, HRT is taking a stand and leading the way in providing access to lifesaving naloxone. Visit www.harmreductiontherapeutics.org to learn more.