HARM REDUCTION THERAPEUTICS


Associated tags: Naloxone, HRT, Drug development, Harm reduction, Pharmaceutical industry, OTC, FDA, Emergency, Therapy, Entrepreneurship, NDA, New Drug Application, Absorption, American Medical Association, Opioid overdose, Food, Regulation of tobacco by the U.S. Food and Drug Administration, Pharmacy, Doctor of Philosophy, Centers for Disease Control and Prevention timeline

First Shipment of RiVive(TM) Brings Life-saving Over-The-Counter Nalxone Nasal Spray One Step Closer to Those Who Need It Most

Retrieved on: 
Monday, December 18, 2023
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Remedy Alliance has also made an additional purchase of about 28,000 twin packs of RiVive.

Key Points: 
  • Remedy Alliance has also made an additional purchase of about 28,000 twin packs of RiVive.
  • By funding organizations like HRT or Remedy Alliance, you can help to prevent further deaths from opioid overdoses."
  • If the person does not respond after 2-3 minutes, additional doses of RiVive may be given until the person wakes up.
  • RiVive will be exclusively available in twin packs containing two single-dose devices, initially to community organizations and governments.

FDA Approval of RiVive(TM) Is a Critical Milestone in Making Emergency Treatment of Opioid Overdose More Widely Available

Retrieved on: 
Friday, July 28, 2023
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This critical milestone will help prevent opioid overdose deaths by making free or low-cost over-the-counter (OTC) naloxone nasal spray available to everyone in the United States.

Key Points: 
  • This critical milestone will help prevent opioid overdose deaths by making free or low-cost over-the-counter (OTC) naloxone nasal spray available to everyone in the United States.
  • As a nonprofit pharmaceutical company, HRT is engaging additional funding partners to help make its affordable opioid overdose treatment more accessible.
  • "2
    HRT began manufacturing RiVive at-risk to minimize the typical lag between FDA approval and launch of a new product.
  • To view an enhanced version of this graphic, please visit:
    The FDA approval of RiVive™ is a critical milestone in making over-the-counter, low-cost emergency treatment of known or suspected opioid overdose widely available across the U.S.
    To view an enhanced version of this graphic, please visit:

Harm Reduction Therapeutics and Catalent Sign Commercial Supply Agreement for Naloxone Nasal Spray to Reverse Opioid Overdoses

Retrieved on: 
Thursday, March 23, 2023
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PITTSBURGH, PA and SOMERSET, N.J., March 23, 2023 /PRNewswire-PRWeb/ -- Harm Reduction Therapeutics, a 501(c)(3) non-profit pharmaceutical company whose mission is to prevent opioid overdose deaths by making low-cost naloxone available to everyone, and Catalent, the leader in enabling the development and supply of better treatments for patients worldwide, today announced the signing of a commercial supply agreement. Under its terms, Catalent will manufacture Harm Reduction Therapeutics' naloxone nasal spray, RiVive™ (3.0 mg), for the emergency treatment of known or suspected opioid overdose.

Key Points: 
  • Under its terms, Catalent will manufacture Harm Reduction Therapeutics' naloxone nasal spray, RiVive™ (3.0 mg), for the emergency treatment of known or suspected opioid overdose.
  • PITTSBURGH, PA and SOMERSET, N.J., March 23, 2023 /PRNewswire-PRWeb/ -- Harm Reduction Therapeutics, a 501(c)(3) non-profit pharmaceutical company whose mission is to prevent opioid overdose deaths by making low-cost naloxone available to everyone, and Catalent, the leader in enabling the development and supply of better treatments for patients worldwide, today announced the signing of a commercial supply agreement.
  • Under its terms, Catalent will manufacture Harm Reduction Therapeutics' naloxone nasal spray, RiVive™ (3.0 mg), for the emergency treatment of known or suspected opioid overdose.
  • The commercial supply agreement comes after the U.S. Food and Drug Administration (FDA) granted Harm Reduction Therapeutics Priority Review status on December 26, 2022, for its over-the-counter (OTC) naloxone nasal spray New Drug Application.

Harm Reduction Therapeutics' New Drug Application for RiVive™ Over-the-Counter Naloxone Nasal Spray Accepted and Granted Priority Review by FDA

Retrieved on: 
Monday, December 26, 2022
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PITTSBURGH, Dec. 26, 2022 /PRNewswire/ -- Harm Reduction Therapeutics (HRT), Inc., a 501(c)(3) nonprofit pharmaceutical company whose mission is to prevent opioid overdose deaths by making free or low-cost over-the-counter (OTC) naloxone nasal spray available to the public, today announced that the FDA has accepted its New Drug Application (NDA) for OTC RiVive (3.0 mg intranasal naloxone) for the emergency treatment of opioid overdose. The RiVive NDA was also granted Priority Review, heralding a long-awaited milestone after public health experts1 and the FDA2 called for naloxone to be made available OTC. Harm Reduction Therapeutics expects to hear from the FDA regarding the approval of RiVive by April 28, 2023.

Key Points: 
  • Low-cost, over-the-counter naloxone nasal spray advances to FDA review.
  • The RiVive NDA was also granted Priority Review, heralding a long-awaited milestone after public health experts1 and the FDA2 called for naloxone to be made available OTC.
  • Harm Reduction Therapeutics expects to hear from the FDA regarding the approval of RiVive by April 28, 2023.
  • "When we formed Harm Reduction Therapeutics in 2017, we saw the urgent need to develop an OTC naloxone product, an action that no other company had pursued.

Over-the-Counter Naloxone One Step Closer as Harm Reduction Therapeutics Initiates a Rolling Submission of its New Drug Application (NDA) to U.S. Food and Drug Administration for RiVive™ (3.0 mg intranasal naloxone) for Emergency Treatment of Opioid Ove

Retrieved on: 
Tuesday, October 11, 2022
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PITTSBURGH, Oct. 11, 2022 /PRNewswire/ -- Harm Reduction Therapeutics (HRT), Inc., a 501(c)(3) nonprofit pharmaceutical company whose mission is to prevent opioid overdose deaths by making free or low-cost over-the-counter (OTC) naloxone available to everyone, today announced the filing of the first module of its New Drug Application (NDA) for RiVive (3.0 mg intranasal naloxone), as an OTC emergency treatment for opioid overdose. The module was submitted to the U.S. Food and Drug Administration (FDA) in accordance with HRT's rolling review proposal accepted by the FDA after it granted Fast Track status to the application in July 2022.

Key Points: 
  • The module was submitted to the U.S. Food and Drug Administration (FDA) in accordance with HRT's rolling review proposal accepted by the FDA after it granted Fast Track status to the application in July 2022.
  • The foundation for an OTC, easy-to-use intranasal naloxone product indicated for the emergency treatment of opioid overdose was laid over 50 years ago when the FDA first approved naloxone as safe and effective.
  • However, despite the ongoing opioid epidemic, the prescription status and high cost of naloxone products continues to limit access to this lifesaving drug.
  • Harm Reduction Therapeutics (HRT), Inc. is a 501(c)(3) non-profit pharmaceutical company whose mission is to prevent opioid overdose deaths by making free or low-cost over-the-counter naloxone available to everyone.

Harm Reduction Therapeutics Announces That Its Naloxone Nasal Spray Met Its Primary Endpoints in a Phase 1 Clinical Trial

Retrieved on: 
Tuesday, March 1, 2022
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PITTSBURGH, March 1, 2022 /PRNewswire/ --Harm Reduction Therapeutics (HRT), a 501c3 nonprofit pharmaceutical company, announced today positive results from its pivotal Phase 1 clinical trial of their 3.0 mg naloxone nasal spray (HRT001) in healthy adult volunteers.

Key Points: 
  • PITTSBURGH, March 1, 2022 /PRNewswire/ --Harm Reduction Therapeutics (HRT), a 501c3 nonprofit pharmaceutical company, announced today positive results from its pivotal Phase 1 clinical trial of their 3.0 mg naloxone nasal spray (HRT001) in healthy adult volunteers.
  • Results confirmed rapid early absorption of naloxone from HRT001 comparable to the FDA reference listed drug, 0.4 mg intramuscular naloxone.
  • "We could not sit by and watch as thousands die from lack of access to an affordable OTC naloxone product.
  • The primary objective was to assess the relative bioavailability of 3.0 mg of HRT001 intranasal naloxone relative to 0.4 mg of intramuscular naloxone.