U.S. FDA Approves Prescription-Free Sale of Second Opioid Overdose Reversal Drug

Introduction

The U.S. Food and Drug Administration (FDA) has approved the prescription-free sale of the second opioid overdose reversal drug, RiVive, according to its manufacturer Harm Reduction Therapeutics.

Over-the-Counter Option for Patients

The approval of RiVive provides patients with another over-the-counter option in the United States, where drug-related overdose deaths surpassed 100,000 in 2021.

Availability and Distribution

Harm Reduction Therapeutics anticipates that RiVive will be available early next year, primarily to harm-reduction organizations and state governments. The not-for-profit drugmaker plans to make at least 200,000 doses available for free.

RiVive: Nasal Spray Version of Naloxone

RiVive is a nasal spray version of naloxone, which rapidly reverses or blocks the effects of opioids, restoring normal respiration, especially when given within minutes of the first signs of an overdose.

Lowering the Cost and Increasing Accessibility

• The company’s co-founder and CEO, Michael Hufford, stated that with partners’ support, they can lower the cost of RiVive or increase the amount given away for free.

Previous Approval of OTC Narcan

In March, Emergent BioSolutions received FDA approval for the first over-the-counter version of Narcan, another naloxone-based spray.

Manufacturing Partnership

Harm Reduction Therapeutics has partnered with contract drug manufacturer Catalent Inc to manufacture RiVive.

Conclusion

The approval of RiVive as a prescription-free opioid overdose reversal drug provides patients with another accessible option to combat the rising number of drug-related overdose deaths in the United States.

Reporting by Sriparna Roy and Bhanvi Satija in Bengaluru; Editing by Pooja Desai

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