According to Harm Reduction Therapeutics (HRT), the court handling the bankruptcy of Purdue Pharma has approved an additional $9 million in Purdue funds to be used by HRT to prepare for possible commercialization of RiVive intranasal naloxone. HRT notes that “neither Purdue nor any of its creditors will receive any revenues, royalties, or profits associated with potential future sales of HRT’s OTC naloxone nasal spray.”
In December 2022, the FDA accepted HRT’s NDA for RiVive with a goal of completing its review of the application by April 28, 2023. The non-profit company says that it is planning for an early 2024 launch if the nasal spray is approved.
HRT CEO Michael Hufford commented, “With growing support among both the public and government health agencies toward expanding naloxone access with OTC products, we are on the brink of a major inflection point in our mission to prevent opioid overdose deaths. RiVive has been developed as a low-cost, easily obtainable medicine to protect families and communities from overdose deaths, and we look forward to making it available as widely and cheaply as possible, after FDA approval.”
Purdue Pharma President and CEO Craig Landau said, “We are grateful to our creditors for their support of this important effort to help abate the opioid crisis and save lives by making naloxone nasal spray more accessible and affordable. We appreciate FDA’s support of the development of OTC naloxone products that will expand access to this lifesaving medication, and we are proud to support HRT’s work to get this product into the hands of people who need it.”
Read the Harm Reduction Therapeutics press release.
