STAMFORD, Conn.--(BUSINESS WIRE)--The Bankruptcy Court today approved Purdue Pharma providing Harm Reduction Therapeutics (HRT) up to $9 million in additional financial support to fund commercial readiness for HRT’s low-cost over-the-counter (OTC) intranasal naloxone spray, tradename RiVive.* Naloxone is an opioid antagonist rescue medication used to reverse the effects of a life-threatening opioid overdose.1
HRT is an independent, 501(c)(3) non-profit pharmaceutical company whose sole mission is to prevent opioid overdose deaths by making low-cost intranasal naloxone available as an OTC product. In support of HRT’s mission, since 2018 Purdue has provided financial contributions, technical expertise, and rights to data. The additional funding approved today will help HRT continue its work toward making OTC naloxone nasal spray available to the public.
“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,” said Craig Landau, MD, President and CEO of Purdue Pharma. “We appreciate FDA’s support of the development of OTC naloxone products that will expand access to this lifesaving medication,2 and we are proud to support HRT’s work to get this product into the hands of people who need it.”
In December 2022, FDA accepted and granted priority review to HRT’s New Drug Application for RiVive™. HRT anticipates an approval decision from FDA in July 2023. Pending FDA approval, HRT expects to launch in the U.S. in early 2024.
“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,” said Dr. Michael Hufford, Co-Founder and Chief Executive Officer of Harm Reduction Therapeutics. “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.”
Consistent with previous funding commitments to HRT, 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.
*This information discusses investigational use of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that OTC naloxone intranasal spray will successfully complete development or gain FDA approval.
About Purdue Pharma L.P.
Purdue Pharma and its subsidiaries develop, manufacture and market medications and consumer health products to meet the evolving needs of healthcare professionals, patients, consumers and caregivers. If consummated, Purdue’s plan of reorganization will deliver billions in value to communities across the country to fund programs specifically for abatement of the opioid crisis. The bankruptcy settlement would also deliver funds to private abatement trusts for the benefit of personal injury claimants.
Substantially all of Purdue’s assets would be transferred to a new post-emergence company with a public-minded mission. This new company would be governed by new independent board members, and would operate in a responsible and sustainable manner taking into account long-term public health interests relating to the opioid crisis. The company would continue serving patients and consumers who rely on its medicines and products, pursuing its pipeline, and introducing medicines that will help save and improve lives.
For more information, visit www.purduepharma.com.
1 National Institute on Drug Abuse. Naloxone for Opioid Overdose: Life-Saving Science. March 30, 2017. Accessed November 22, 2022. https://nida.nih.gov/publications/naloxone-opioid-overdose-life-saving-science.
2 Federal Register. Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use; Request for Comments. 87 FR 68702. 17. Document Number 2022-24874. United States Food and Drug Administration. November 16, 2022. Accessed November 22, 2022. https://www.federalregister.gov/documents/2022/11/16/2022-24874/safety-and-effectiveness-of-certain-naloxone-hydrochloride-drug-products-for-nonprescription-use.