The US Food and Drug Administration (FDA) approved Harm Reduction Therapeutics’ RiVive, a 3-milligram naloxone hydrochloride nasal spray, for over-the-counter (OTC), nonprescription use for the emergency treatment of known or suspected opioid overdose.
This is the second nonprescription naloxone product the agency has approved. The agency approved the first product in March 2023. The timeline for availability and the price of RiVive will be determined by the manufacturer.
“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,” says FDA commissioner Robert M. Califf, MD, in a release. “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 labeling. 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, 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.
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, according to a release from the FDA. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose.
Photo caption: RiVive naloxone hydrochloride nasal spray
Photo credit: Harm Reduction Therapeutics