Harm Reduction Therapeutics

Harm Reduction Therapeutics is a 501(c)(3) nonprofit pharmaceutical company founded to save lives by making naloxone available over-the-counter free of charge or at the lowest possible cost.

With FDA approval of OTC RiVive™ OTC (naloxone HCl nasal spray 3 mg) for the emergency treatment of opioid overdose, we are advancing our manufacturing with the goal of making our first shipment early 2024.

HRT is focused on supplying RiVive™ OTC to communities who need it most and will make at least 200,000 doses (10% of projected initial annual product production) available free of charge.


No company, entity, or individual will profit from sales of RiVive™ OTC.


Our single objective is to save lives that would have otherwise been lost to opioid overdose by making OTC low-price naloxone available to everyone in the United States.

The CDC reports that tens of thousands of lives have been saved since 1996. Naloxone has been shown to be successful in reversing overdoses in 98.8% of cases.

“Because of naloxone I’m able to have another chance at life”

– Roger D.

As a nonprofit 501(c)(3) pharmaceutical company, you can help us achieve our mission of putting easy-to-use life-saving naloxone into the hands of every American.

No company, entity, or individual will profit from sales of RiVive™ OTC. including our unpaid volunteer Board of Directors and minimal staff who receive no additional compensation as sales are made.

RiVive™ OTC which can save lives, will be available at cost or less, with its initial selling price set at $36 per twin pack. This price covers the hard costs (ingredients, nasal spray devices, vials) and production, packaging, testing and transportation costs, which comprise 92% of RiVive OTC’s overall cost, plus HRT’s virtual organization’s minimal costs to coordinate manufacturing and distribution, meet ongoing regulatory obligations, and run the nonprofit (8%).

Funding partners are required to sustain operations, including manufacturing. Funders can direct their financial support to further lowering the price of RiVive™ OTC, making more of it available free of charge to specific U.S. nonprofit harm reduction organizations, and/or helping to increase manufacturing capacity so that more lives can be saved.


Michael R Hufford, PhD


Michael Hufford

Michael Hufford has spent 20 years as an entrepreneur, co-founding multiple pharmaceutical, medical device, and mobile health companies. He’s raised money from both public and private markets, including VCs and angel investors.

He’s led pharmaceutical development teams through FDA approvals, as well as supporting Rx-to-OTC switches.

An addiction researcher by training, he received his PhD from the University of Pittsburgh and completed a Clinical and Research Fellowship in the Department of Psychiatry at Harvard Medical School.

John Pinney


John Pinney

John has spent 45 years in the fields of disease prevention, substance abuse, health policy, and pharmaceutical consulting. His experience includes a wide range of executive positions in government, nonprofit, and academic organizations.

John has consulted on numerous major Rx-to-OTC switch, drug development, issues management and product stewardship projects.

In 1994, he founded PinneyAssociates to focus on consulting to the pharmaceutical industry, bringing a wealth of experience to help develop solutions to complex regulatory challenges and public health problems.

James E. Kelly

President and General Manager

Jim has served in senior Marketing, Sales and General Mangement positions in the consumer healthcare industry for 30+ years at Warner Lambert, Combe Incorporated and Prestige Consumer Healthcare. He has also led private equity backed ventures as CEO and consulted for a wide variety of small, entrepreneurial firms in the industry during his career.
Jim has led a broad array of household brand names and has operated in over 30 different OTC and personal care therapeutic categories that include OTC medications, medical devices and dietary supplements. He earned his BA from Rutgers College and his MBA from Rutgers Business School.
Here at HRT, Jim is responsible for leading all commercial functions including operations, supply chain, marketing and sales of the RiVive brand.

Judy Ashworth, MD


Judy has over 20 years of experience in pharmaceutical drug development starting in 2001 at Gruenenthal GmbH, primarily focused on the development of innovative pain medications.

During her time as a visiting lecturer at Columbia University’s Department of Substance Abuse Research, she participated in the Tufts Health Care Institute’s Program on Opioid Risk Management.

In 2018, Judy joined PinneyAssociates to provide clients with strategic input into target product profile development, clinical development plans and regulatory strategy.

As the Chief Medical Officer at HRT, Judy is responsible for the strategy, direction, and execution of the company’s clinical development plans.

Harm Reduction Therapeutics is a 501(c)(3)nonprofit pharmaceutical company focused on increasing access to free or low-cost naloxone. Its work has been funded by private donors and by contributions from Purdue Pharma approved (since 2020) by the bankruptcy court administering Purdue Pharma’s chapter 11 proceedings.

For more information on donating to support our work, please contact us at financialsupport@harmreductiontherapeutics.org