Over-the-Counter RiVive Approved for Treatment of Opioid Overdose

The Food and Drug Administration (FDA) has approved RiVive^™, an over-the-counter (OTC) naloxone nasal spray, for the emergency treatment of known or suspected opioid overdose.

RiVive is an opioid antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension. The approval was based on a phase 1 clinical trial that demonstrated systemic exposure with RiVive was comparable to a reference naloxone product. Additional data showed individuals were able to administer RiVive safely and effectively in a simulated emergency overdose situation.

According to manufacturer Harm Reduction Therapeutics, a nonprofit pharmaceutical company, the product will be available for free or at a low cost. Each RiVive nasal spray unit contains 3mg of naloxone HCl and delivers a single dose. The packaging will include 2 single-dose devices and is expected to be available in early 2024.

This is the second naloxone product approved for nonprescription use. In March 2023, the FDA granted approval to an OTC version of Narcan nasal spray. Additionally, the first generic nonprescription naloxone nasal spray product received approval in July 2023.

“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 “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.”