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.
With FDA approval of OTC RiVive™ (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™ to communities who need it most and will make at least 200,000 doses (10% of projected initial annual product production) available for free.
No company, entity, or individual will profit from sales of RiVive™
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™. including our unpaid volunteer Board of Directors and minimal staff who receive no additional compensation as sales are made.
RiVive™, 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 (inactive ingredients, devices, vials) and production, packaging, testing and transportation costs (92% of the price) plus the virtual organization’s minimal administration costs (8%).
Funding partners are required to sustain operations, including manufacturing. Funders can direct their financial support to further lowering the price of RiVive™, making more of it available free 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 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 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
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 email@example.com.