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 for free or at the lowest possible cost. Free from a profit motive, with investors and partners committed to our life-saving mission, our goal is to launch an FDA-approved product as soon as possible.

To save lives, naloxone needs to be affordable and available OTC


Our objective is to save lives by making OTC low-price naloxone available to everyone. Naloxone is proven to work. Both the CDC and local communities report that making naloxone accessible saves lives.

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.


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.

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.

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.

Bernie Simone


Bernie has over 30 years of experience in the OTC industry including marketing, business development and Rx-to-OTC switches. He’s been involved in projects spanning 40 therapeutic categories across OTC medicines, prescription drugs, medical devices, and dietary supplements.

As Head of Rx-to-OTC Switches for Sanofi CHC North America, Bernie was responsible for Switch Team leadership. His most recent successes include the first-in-class switch of Nasacort 24HR, the first-in-class OTC TENS, medical device and the switch of Xyzal Allergy 24HR.

Here at HRT, Bernie serves as the Chief Operating Officer, while also responsible for consumer marketing and interactions with the FDA.

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 support@harmreductiontherapeutics.org.