FDA approves OTC naloxone nasal spray product for opioid overdose

USA: RiVive, 3 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), has received approval from the U.S. Food and Drug Administration (FDA) for nonprescription use for the emergency treatment of known or suspected opioid overdose.

This is the second nonprescription naloxone product the agency has approved, helping increase consumer access to naloxone without a prescription. The timeline for availability and the price of this nonprescription product will be determined by the manufacturer.

Drug overdose persists as a major public health issue in the United States. In the 12-month period ending in February 2023, more than 105,000 reported fatal overdoses occurred which were primarily driven by synthetic opioids like illicit fentanyl. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose.

“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, M.D. “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.”

The approval of RiVive nasal spray for nonprescription use was supported by data from a study submitted by the manufacturer that showed similar levels of RiVive reach the bloodstream as an approved prescription naloxone product. The drug has been demonstrated to be safe and effective for use as directed in its labelling. The manufacturer also provided data that showed consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.

The use of RiVive nasal spray in individuals who are dependent on opioids may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.

The FDA has taken a series of steps to help facilitate access to opioid overdose reversal products and to decrease unnecessary exposure to opioids and prevent new cases of addiction. The agency approved the first nonprescription naloxone nasal spray product in March 2023, the first generic nonprescription naloxone nasal spray product in July 2023 and over the last year has undertaken new efforts to expand opioid disposal options in an effort to reduce opportunities for nonmedical use, accidental exposure and overdose.

Through the FDA Overdose Prevention Framework, the agency remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose and death in the U.S. The framework’s priorities include supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted or counterfeit drugs presenting overdose risks.

The FDA granted the nonprescription approval of RiVive to Harm Reduction Therapeutics.