FDA Approves Naloxone Nasal Spray for OTC Use to Combat Opioid Overdose Crisis

In a significant move to address the ongoing drug overdose crisis in the US, the US Food and Drug Administration (FDA) has granted approval for RiVive, a 3 milligram (mg) naloxone hydrochloride nasal spray, to be available over-the-counter (OTC) for nonprescription use.¹

“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,” Robert Califf, MD, FDA Commissioner, said in a statement.

The nasal spray is intended for the emergency treatment of known or suspected opioid overdoses, offering a critical tool to combat the rising number of fatal overdoses in the country. The approval of RiVive marks the second nonprescription naloxone product to be given the green light by the FDA, signaling a proactive effort to increase accessibility and consumer availability of this life-saving medication without the need for a prescription.²

“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,” Califf said.¹

Opioid overdose remains a pressing public health concern, and recent data highlight the severity of the crisis. Over the 12-month period leading up to February 2023, there were more than 105,000 reported fatal overdoses, with synthetic opioids like illicit fentanyl being a major driver of these fatalities.

The FDA's decision to approve RiVive for nonprescription use was supported by robust data from studies conducted by the manufacturer. The data demonstrated that RiVive nasal spray achieved similar levels of effectiveness as an FDA-approved prescription naloxone product.

Additionally, the study indicated that consumers can safely and effectively use RiVive without the supervision of a healthcare professional, making it a suitable OTC product.

However, it is important to note that the use of RiVive nasal spray in individuals who are dependent on opioids may lead to severe opioid withdrawal symptoms, which include a range of physical and psychological effects. Therefore, careful adherence to the product's labeling and instructions is crucial to ensuring safe and effective usage.

According to the agency’s statement, Harm Reduction Therapeutics, the manufacturer of RiVive, will be responsible for determining the timeline for availability and the price of the nonprescription product.

As the OTC RiVive product becomes available to consumers, it is essential to ensure that awareness and education about its proper use are widely disseminated to maximize its potential to save lives and combat the opioid overdose crisis effectively.

References:

1. FDA Approves Second Over-the-Counter Naloxone Nasal Spray Product. News Release. FDA. July 28, 2023. Accessed July 28, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-second-over-counter-naloxone-nasal-spray-product
2. Pine L. FDA Approves Nalmefene Nasal Spray for Opioid Overdose. HCPLive. May 23, 2023. https://www.hcplive.com/view/fda-approves-nalmefene-nasal-spray-for-opioid-overdose