RiVive™ is FDA Approved

FDA has approved over-the-counter RiVive™ (naloxone HCl nasal spray 3 mg) for the emergency treatment of opioid overdose.

This critical milestone advances the pursuit of HRT’s mission to prevent opioid overdose deaths by making free of charge or low-cost over-the-counter naloxone available to everyone across the United States.

HRT anticipates RiVive™ will be available by early 2024 primarily to U.S. harm reduction organizations and state governments for costs lower than other opioid antagonist nasal sprays.

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

RiVive™ (naloxone HCl nasal spray 3 mg) is a novel over-the-counter intranasal formulation of naloxone (3.0 mg) delivered as an atomized spray (0.1 ml) that can save lives. It uses an easy-to-use standard unit dose system for single administration for the emergency treatment of opioid overdose without a prescription. RiVive™ produces a 3-fold higher systemic exposure with comparable early absorption to the reference naloxone product, as well as robust Human Factors Validation work demonstrating that laypeople are able to administer RiVive™ in a simulated emergency overdose situation.

Warning: when using this product, some people may experience symptoms when they wake up such as shaking, sweating, nausea, or feeling angry.

SAVING LIVES BY MAKING NALOXONE AVAILABLE TO EVERYONE

As a 501(c)(3) nonprofit pharmaceutical company, you can join our mission to save lives that would have otherwise been lost to opioid overdose.

We are seeking funding partners to sustain manufacturing operations and broaden distribution. 

Funders can direct their financial support to further lowering the price of RiVive™, 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.

 

 

“My daughter’s here today because she was administered naloxone”
– Mary J.
Harm Reduction Therapeutics
Harm Reduction Therapeutics is a nonprofit pharmaceutical company that has developed and achieved FDA approval of an over-the-counter naloxone nasal spray to help save lives that would otherwise be lost to the ongoing opioid epidemic.

DRIVEN BY ONE MISSION

We strive 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.

Michael R Hufford, PhD
Co-Founder & Chief Executive Officer

We know what strategies work and what we need to do to end this epidemic

– Surgeon General Vivek Murthy

“No one who needs overdose reversal medications should lack access because of costs or availability.”

– White House and Office of National Drug Control Policy Director Dr. Rahul Gupta

“This crisis is killing a New Yorker every three hours and is impacting every individual and family in our city and in our nation. No one is spared, even if you think otherwise. If you use drugs, know someone who is using drugs, or might be around drug use, there are simple steps we can take. First, everyone should carry naloxone, get trained to use it and to recognize the signs of overdose…”

– New York City Health Commissioner Dr. Ashwin Vasan.

“In the midst of this fentanyl overdose epidemic, it is important to focus on measures to prevent youth drug use and ensure that every school has naloxone and has prepared its students and faculty to use it.”

-U.S. Secretary of Education Miguel A. Cardona, Ed.D. and White House and Office of National Drug Control Policy Director Dr. Rahul Gupta

RiVive – OTC Naloxone

U.S. harm reduction organizations, state and other government procurement functions can order FDA-approved RiVive™ (naloxone HCl nasal spray 3 mg) for the emergency treatment of opioid overdose by contacting (888) 412-7454 or sales@harmreductiontherapeutics.org.

RiVive™ is currently being manufactured and anticipates first shipment early 2024.

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 (ingredients, nasal spray devices, vials) and production, packaging, testing and transportation costs, which comprise 92% of RiVive’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%).

Rivive Nasal Spray 3mg naloxone HCL Emergency Treatment of Opioid Overdose

With additional funding partners, 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 free of charge.

To help HRT save lives that would have otherwise been lost to opioid overdose, contact Dr. Michael Hufford financialsupport@harmreductiontherapeutics.org

“Overdose reversal medications save lives, and no one should lack access because of affordability or availability.”

– Dr. Gupta

PROVEN TO SAVE LIVES

  • Naloxone has been shown to be successful in reversing overdoses in 98.8% of cases.1
  • The CDC reports that tens of thousands of lives have been saved since 1996.2
  • A national study showed overdose deaths decreased by 14% in states that enacted naloxone access laws.3
  • Statistical modeling indicates that greater naloxone availability could reduce overdose deaths by 21%.4
“If it wasn’t for naloxone I wouldn’t be where I was at today”
– Roger T.
1. Avetian, et al. (2018) DOI: 10.1080/03007995.2017.1334637
2. Wheeler, E., et al., Opioid Overdose Prevention Programs Providing Naloxone to Laypersons, 2014
3. McClellan, C., et al., Opioid-overdose laws association with opioid use and overdose mortality. Addictive Behaviors, 2018. 86: p. 90-95.
4. Townsend, T., et al., Cost-effectiveness analysis of alternative naloxone distribution strategies: First responder and lay distribution in the United States. International Journal of Drug Policy, 2019.