FDA Approves OTC Opioid Overdose Treatment

On July 28, 2023, FDA approved RiVive, 3 mg naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use as emergency treatment of confirmed or suspected opioid overdose. This product is the second nonprescription naloxone FDA has approved, increasing consumer non-prescriptive access to naloxone. The manufacturer will determine the timeline for availability and the price of this product.

A study from the manufacturer showed comparable levels of RiVive reach the bloodstream as an approved prescription naloxone product. The drug showed it was safe and effective for use as outlined in its labeling. The manufacturer submitted data exhibiting consumers can comprehend how to safely and effectively use RiVive without a healthcare professional’s supervision.

“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 in an FDA press 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.”

Drug overdose continues to be a major public health concern in the United States. Over 105,000 fatal overdoses were reported in the 12-month period ending in February 2023, most of which were driven by synthetic opioids such as illicit fentanyl. Naloxone, which quickly reverses the effects of opioid overdose, is the standard treatment for opioid overdose.

Individuals who are dependent on opioids may experience severe opioid withdrawal while using RiVise, whose symptoms include the following: body aches, increased heart rate (tachycardia), diarrhea, runny nose, fever, sneezing, goose bumps, yawning, sweating, nervousness, restlessness or irritability, nausea or vomiting, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

This approval is part of a series of steps FDA has taken to enable better access to products that treat opioid overdose, while reducing opioid exposure and curbing new cases of addiction. Other products approved by the agency include the first generic nonprescription naloxone nasal spray product in March 2023 and the first generic nonprescription naloxone nasal spray product in July 2023. Over the last year, the FDA endeavored to decrease the non-medical use, accidental exposure, and overdose of opioids, with new programs such as the Remove the Risk outreach toolkit. FDA wrote that it “remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose and death in the U.S.”

Source: FDA