FDA Approves Harm Reduction Therapeutics' Over-the-Counter Opioid Overdose Reversal Medication

FDA has approved Harm Reduction Therapeutics' (HRT) new drug application for RiVivetm (Naloxone HCl Nasal Spray 3 mg) to be available over the counter (OTC) for the emergency treatment of opioid overdose. Naloxone is an opioid antagonist rescue medication used to reverse the effects of a life-threatening opioid overdose. As an independent, 501(c)(3) non-profit pharmaceutical company, HRT's mission is to prevent opioid overdose deaths by making low-cost intranasal naloxone available to everyone without a prescription.

Since 2018, Purdue has supported HRT's mission by contributing millions of dollars, extensive technical expertise, and rights to important data to support the development of this opioid overdose reversal medication. Purdue's support for HRT is a vital part of the Company's Public Health Initiatives which, as important elements of its Plan of Reorganization, are intended to help abate the opioid crisis.

"We are proud to have long supported HRT's mission, and we congratulate them on this major milestone that enables the future delivery of an accessible, affordable version of this life-saving medication to those who need it most," said Craig Landau, MD, President and CEO of Purdue Pharma. "We thank our creditors who have made it possible for us to fund work that will help abate the opioid crisis and save lives."

The American Medical Association,¹ Food and Drug Administration,² US Surgeon General,³ Centers for Disease Control,⁴ and other leading health organizations and public entities have acknowledged naloxone's role in addressing the opioid crisis and the importance of making naloxone available over-the-counter to improve access among communities in need. FDA has also expressed its commitment to facilitating greater access to naloxone and encouraging the development of additional OTC naloxone products.⁵

"With FDA's approval of RiVive, we have achieved a pivotal and long-awaited milestone that enables HRT to help save lives that could otherwise be lost to opioid overdose," said Michael Hufford, PhD, Co-Founder and CEO of Harm Reduction Therapeutics. "The support of Purdue's creditors has significantly advanced our sustainable non-profit approach to making RiVive available without a prescription. HRT's focus now transitions from development to manufacturing and distribution as we work to make RiVive widely and cheaply available across the United States."

Neither Purdue nor any of its creditors will receive any revenues, royalties, or profits associated with potential future sales of HRT's RiVive.

About Purdue Pharma L.P.

Purdue Pharma and its subsidiaries develop, manufacture and market medications to meet the evolving needs of healthcare professionals, patients, and caregivers. 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 will 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 will be governed by new independent board members, and will operate in a responsible and sustainable manner taking into account long-term public health interests relating to the opioid crisis. The company will continue serving patients who rely on its medicines, pursuing its pipeline, and introducing medicines that will help save and improve lives.

For more information, visit www.purduepharma.com.

References

1. AMA statement on making naloxone available over the counter. March 29, 2023. https://www.ama-assn.org/press-center/press-releases/ama-statement-making-naloxone-available-over-counter. Accessed June 15, 2023.
2. https://www.fda.gov/news-events/press-announcements/fda-announces-preliminary-assessment-certain-naloxone-products-have-potential-be-safe-and-effective.
3. https://www.whitehouse.gov/ondcp/briefing-room/2021/11/19/excerpts-from-dr-guptas-remarks-at-ceremonial-swearing-in-at-the-white-house/.
4. https://www.cdc.gov/stopoverdose/naloxone/index.html.
5. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-unprecedented-new-efforts-support-development-over.

MR-08400