Second OTC Naloxone Nasal Spray Approved by FDA

In July, the FDA approved 3 mg naloxone hydrochloride nasal spray, an over-the-counter (OTC) product used for known or suspected opioid overdose. This is the second nonprescription naloxone nasal product approved by the FDA since March.

According to the FDA, more than 105,000 reported fatal overdoses occurred in the 12-month period ending in February 2023, most of which were caused by synthetic opioids like illegal fentanyl.

Recognizing that drug overdoses remain a major public health issue in the United States, the FDA has focused its attention on increasing consumer access to products that can rapidly reverse the effects of 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,” Robert M. Califf, MD, FDA Commissioner, said in a 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.” 

The approval follows the results of a recent study from the product manufacturer, which showed that the levels of naloxone hydrochloride nasal spray that reached the bloodstream were similar to those of an approved prescription naloxone product.

Although the product has been deemed safe and effective for use as directed, the FDA press release noted that the use of the nasal spray by individuals who are dependent on opioids may result in severe opioid withdrawal symptoms including, body aches, diarrhea, 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.

Reference

FDA approves second over-the-counter naloxone nasal spray product. News release. US Food and Drug Administration; July 28, 2023. Accessed September 27, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-second-over-counter-naloxone-nasal-spray-product