Stamford, Conn., March 23, 2022 – Harm Reduction Therapeutics (HRT) will receive up to $11 million of additional financial support from Purdue Pharma L.P. to advance its development of a low-cost, over-the-counter (OTC) naloxone nasal spray in the United States. Naloxone is an opioid antagonist rescue medication used to reverse the effects of a life-threatening opioid overdose.
HRT is an independent, non-profit pharmaceutical company focused on helping 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. HRT plans to file a New Drug Application for naloxone nasal spray with FDA in 2022. If approved, this medication would become available over the counter and at a substantially lower retail cost than current naloxone nasal spray products.
“The CDC and other leading health organizations have acknowledged naloxone is a non-addictive, life-saving drug that can reverse the effects of an opioid overdose when administered in time.1 In addition, the American Medical Association has called on the federal government to remove the prescription status of naloxone to make it more available over the counter.2 However, access to naloxone remains a challenge for many communities in the U.S.,” said Craig Landau, MD, President and CEO, Purdue Pharma. “We believe that this medicine, if it receives FDA approval, has the potential to make naloxone nasal spray more accessible and affordable. We and our stakeholders – which consist of all opioid claimants - are committed to helping address the opioid crisis.”
“At HRT, we are driven by a commitment to help prevent opioid overdose deaths by working to make naloxone available to everyone. With lives lost every day from opioid overdoses, ensuring broader access to affordable, over-the counter naloxone is an urgent priority,” said Michael Hufford, PhD, Co-Founder and CEO, Harm Reduction Therapeutics. “We are continuing to advance the development of OTC naloxone nasal spray to help communities across the country affected by the opioid crisis.”
Purdue’s agreement with HRT to provide additional funding was approved by the Bankruptcy Court. Consistent with previous commitments, 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.
About Harm Reduction Therapeutics, Inc.
Harm Reduction Therapeutics (HRT) is a 501c3 non-profit pharmaceutical company whose mission is to prevent opioid overdose deaths by making low price 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, please visit www.harmreductiontherapeutics.org.
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- Reverse Overdose to Prevent Death. November 17, 2021. https://www.cdc.gov/opioids/overdoseprevention/reverse-od.html. Accessed March 1, 2022.
- American Medical Association. AMA urges Administration to remove naloxone from behind the counter. February 15, 2022. https://www.ama-assn.org/press-center/press-releases/ama-urges-administration-remove-naloxone-behind-counter. Accessed March 1, 2022.