FDA Alerts

FDA Approves Over-The-Counter Naloxone Spray for Opioid Overdoses

Jessica Ganga

Drug and opioid overdose continue to be a growing public health issue in the United States, with more than 100,000 reported deaths due to overdoses reported in a 12-month period ending in October 2022, according to a press release. To combat the opioid crisis, the FDA has approved the first over-the-counter (OTC) naloxone hydrochloride nasal spray, the first product approved for use without a prescription.

“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” said FDA Commissioner Robert M. Califf, MD, in a press release.

In 2015, the FDA first approved the nasal spray as a prescription treatment. The medication changed from prescription to OTC after the manufacturer, in accordance with a process to change the status, submitted data that “the drug is safe and effective for use as directed in its proposed labeling.” Further, the manufacturer showed that consumers can safely and effectively use the medication using the provided instructions.

The timeline for availability and price for the medication will be determined by the manufacturer, and the FDA noted it will continue to help facilitate the availability of naloxone nasal spray products with stakeholders during the time the products switch from prescription to OTC.

“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price,” continued Dr Califf.

Individuals who are opioid dependent and use the nasal spray may experience severe opioid withdrawal, which is characterized by body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, sweating, yawning, nausea or vomiting, nervousness, restlessness, shivering or trembling, abdominal cramps, weakness and increased blood pressure.



FDA approves first over-the-counter naloxone nasal spray. News release. US Food and Drug Administration; March 29, 2023. Accessed April 4, 2023.