STAMFORD, Conn. and PITTSBURGH, Penn., September 5, 2018 – Purdue Pharma L.P. (Purdue) and Harm Reduction Therapeutics, Inc. today announced that Purdue is providing a $3.42 million grant to Harm Reduction Therapeutics to advance the development of its low-cost, over-the-counter (OTC) naloxone nasal spray in the United States. Naloxone is an opioid antagonist used to reverse the effects of a life-threatening opioid overdose.
Harm Reduction Therapeutics is an independent, non-profit pharmaceutical company whose mission is to “prevent opioid overdose deaths by making low-cost naloxone available to everyone.” Purdue’s contributions will help Harm Reduction Therapeutics accelerate the development of its OTC naloxone nasal spray by approximately 12 months.
Currently, naloxone nasal spray, the form of naloxone most commonly used outside of healthcare settings, is a costly medication, and access is limited to behind-the-counter pharmacy distribution through a prescriber or a Health Department’s standing order. Making naloxone available as a low-cost, OTC product will provide a sustainable solution to an important unmet need, significantly increasing access and saving lives.
Harm Reduction Therapeutics anticipates the OTC product will be developed, approved and distributed in 18-24 months. This product will provide a low-cost alternative to prescription naloxone for both consumers and first responders. Given the nature of this grant, no revenues or royalties will be paid to Purdue.
The U.S. Surgeon General, Food and Drug Administration, U.S. Department of Health and Human Services, and The President’s Commission on Combating Drug Addiction and the Opioid Crisis all recommend expanded use of naloxone due to its potential for saving lives. Unfortunately, cost has been a barrier, especially in communities hardest hit by the opioid crisis.1
“Purdue is committed to advancing patient care and public safety. While naloxone accessibility cannot be seen as a single solution, it must be part of our collective actions,” said Craig Landau, MD, president and CEO, Purdue Pharma. “This grant is one example of the meaningful steps Purdue is taking to help address opioid abuse in our communities. Collaborating with a variety of partners is crucial to address the crisis we’re facing, and we are honored to support Harm Reduction Therapeutics as they work to prevent opioid-related deaths by increasing access to naloxone.”
This grant builds on Purdue’s work with law enforcement through a partnership with the National Sheriffs’ Association since 2015.2 Purdue also supports policies to facilitate the availability of naloxone for use in the community, including those that provide the appropriate persons aiding in a potential overdose situation protection through “Good Samaritan” laws.3
“As lives are lost every day from opioid overdoses, making low cost, over-the counter naloxone available to both consumers and first responders is an urgent priority,” said Michael Hufford, PhD, co-founder and CEO, Harm Reduction Therapeutics. “Combatting the ongoing crisis of opioid addiction will require innovative approaches to both prevention and medication-assisted treatment, but it all starts with making sure lives are not lost from overdose. Increasing access to naloxone – by obtaining FDA approval to sell it over-the-counter and selling it at the lowest possible price as a non-profit pharmaceutical company – will help save lives that would otherwise be lost to opioid overdose, and we are grateful to Purdue for their support to help accelerate our drug development.”
About Purdue Pharma
Purdue Pharma L.P. develops and provides prescription medicines that meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians, and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications and technologies through internal research & development and strategic industry partnerships. For more information, please visit www.purduepharma.com.
About Harm Reduction Therapeutics
Harm Reduction Therapeutics is a 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 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.
1 Gupta R, et al. The rising price of naloxone — risks to efforts to stem overdose deaths. N Engl J Med 2016; 375:2213-2215.
2 National Sheriffs’ Association. NSA releases most recent naloxone report – estimates 175 lives saved. Published April 12, 2018. Retrieved from https://www.sheriffs.org/NSA-Releases-Most-Recent-Naloxone-Report-Estimates-175-Lives-Saved. Accessed May 6, 2018.
3 Washington Examiner. Why we support increasing access to naloxone. Published May 16, 2018. Retrieved from: https://www.washingtonexaminer.com/opinion/op-eds/why-we-support-increasing-access-to-naloxone. Accessed August 27, 2018.
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Purdue Pharma L.P.
Harm Reduction Therapeutics, Inc.