Purdue Pharma L.P. to Fund Harm Reduction Therapeutics, Inc.’s Development of Over-the-Counter Opioid Overdose Reversal Medication

Purdue Pharma L.P. and Harm Reduction Therapeutics, Inc. (HRT) announced today that Purdue will provide up to $6.5 million of additional financial support to HRT 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, nonprofit pharmaceutical company focused on decreasing naloxone’s cost and increasing its availability as an OTC product. Since 2018, Purdue has provided financial contributions, technical expertise and rights to data in support of HRT’s mission. The additional financial support announced today will help fund HRT's continued work to develop its naloxone nasal spray for filing as a New Drug Application with the U.S. Food and Drug Administration (FDA). If approved by the FDA, this medication would become available over the counter and at a substantially lower retail cost than current naloxone nasal spray products.

“Many public health experts have noted that putting more naloxone in the hands of friends, family and community members has the potential to save lives. Unfortunately, currently available forms of naloxone can be costly and difficult to obtain,” said Craig Landau, MD, President and CEO, Purdue Pharma. “Purdue strongly believes in HRT’s efforts to make naloxone available as a low-cost, OTC product, and we hope that our support can help make their mission a reality.”

Purdue’s agreement with HRT to provide additional funding was approved during a Bankruptcy Court hearing on June 23. Consistent with previous commitments, Purdue is not expected to receive revenues, royalties, or profits associated with potential future sales of HRT’s OTC naloxone nasal spray.

OTC naloxone is an emergency treatment that may help save lives, and its expanded use is recommended by U.S. Surgeon General, Food and Drug Administration and U.S. Department of Health and Human Services.

“As an independent nonprofit pharmaceutical company, our mission is to prevent opioid overdose deaths by working to make naloxone available to everyone,” said Michael Hufford, PhD, co-founder & CEO, Harm Reduction Therapeutics. “In developing a low-cost OTC naloxone product, we have the opportunity to significantly expand access to this potentially lifesaving medication. Purdue’s support has been crucial to our work as we look to provide a meaningful breakthrough in this ongoing public health crisis.”

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that HRT’s OTC naloxone nasal spray will successfully complete development or gain FDA approval.

About Purdue Pharma L.P.

Purdue Pharma and its subsidiaries develop and provide prescription medicines and consumer products that meet the evolving needs of healthcare professionals, patients, consumers and caregivers. We were founded by physicians and are currently led by a physician. Beyond our efforts to provide quality medications, Purdue Pharma is committed to supporting national, regional and local collaborations to drive innovations in patient care while also continuing our efforts to address the opioid addiction crisis.

Purdue’s subsidiaries include: Adlon Therapeutics L.P., focused on treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) and related disorders; Avrio Health L.P., a consumer health products company that champions an improved quality of life for people in the United States through the reimagining of innovative product solutions; Imbrium Therapeutics L.P., established to further advance the emerging portfolio and develop the pipeline in the areas of CNS, non-opioid pain medicines, and select oncology through internal research, strategic collaborations and partnerships; and Greenfield Bioventures L.P., an investment vehicle focused on value-inflection in early stages of clinical development.

For more information, visit www.purduepharma.com.

About Harm Reduction Therapeutics, Inc.

Harm Reduction Therapeutics is a nonprofit 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 of existing naloxone products, Harm Reduction Therapeutics 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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