FDA Approves Second Naloxone Hydrochloride Nasal Spray for OTC, Nonprescription Use

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The US Food and Drug Administration (FDA) recently announced the approval of naloxone hydrochloride (HCL) nasal spray (RiVive™, Harm Reduction Therapeutics, Inc.) for over-the-counter (OTC), nonprescription use for the emergency treatment of known or suspected opioid overdose.¹

The product was approved at a dose of 3 mg, according to the FDA’s July 28, 2023, press release.

“We know naloxone is a powerful tool to help quickly reverse the effects of opioids during an overdose. Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health,” said FDA Commissioner Robert M. Califf, MD, in the statement. “The agency has long prioritized access to naloxone products, and we welcome manufacturers of other naloxone products to discuss potential nonprescription development programs with the FDA.”¹

RiVive is the second nonprescription naloxone product approved by the FDA. The approval was based on data from a study submitted by the manufacturer that demonstrated “similar levels of RiVive reach the bloodstream as an approved prescription naloxone product,” according to the agency. Harm Reduction Therapeutics also provided data indicating that consumers can safely and effectively use RiVive without the supervision of a health care professional.¹

Harm Reduction Therapeutics is a nonprofit pharmaceutical company and aims to make RiVive available for free or at low breakeven cost, according to a company press release. The company anticipates making approximately 200 000 doses (10% of the projected initial annual product production) available for free.²

“We are grateful that FDA granted RiVive approval so we can now achieve what most thought impossible and no other company has: broad delivery of a lower-cost nasal naloxone product without a prescription to save lives that could otherwise be lost to opioid overdose,” said Michael Hufford, PhD, co-founder and chief executive officer of Harm Reduction Therapeutics, Inc., in the statement.²

According to the manufacturer, each RiVive nasal spray device contains 1 dose of naloxone and will only be available in twin packs containing 2 single-dose devices, and it is safe to keep administering the product every 2-3 minutes until the individual wakens.²

The FDA underscored that use of RiVive in persons who are dependent on opioids may result in severe opioid withdrawal. The timeline for availability and the price of RiVive will be determined by the manufacturer, noted the FDA.¹

References:

1. US Food and Drug Administration. FDA approves second over-the-counter naloxone nasal spray product. FDA News Release. July 28, 2023. Accessed July 31, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-second-over-counter-naloxone-nasal-spray-product

2. Harm Reduction Therapeutics. FDA approval of RiVive™ is a critical milestone in making emergency treatment of opioid overdose more widely available. July 28, 2023. Accessed July 31, 2023. https://www.harmreductiontherapeutics.org/wp-content/uploads/2023/07/HRT-RiVive-Press-Release-July-21-FINAL.pdf