Market Overview

Purdue Pharma L.P. to Fund Harm Reduction Therapeutics, Inc.'s Work to Develop Inexpensive, Over-the-Counter, Life-Saving Naloxone in the United States


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

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

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


1Gupta R, et al. The rising price of naloxone — risks to
efforts to stem overdose deaths. N Engl J Med 2016; 375:2213-2215.
Sheriffs' Association. NSA releases most recent naloxone report –
estimates 175 lives saved. Published April 12, 2018. Retrieved from
Accessed May 6, 2018.
3Washington Examiner. Why we
support increasing access to naloxone. Published May 16, 2018. Retrieved
Accessed August 27, 2018.

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