FDA approves over-the-counter Narcan for opioid OD reversal

On Wednesday, the Food and Drug Administration approved the first over-the-counter nasal spray that rapidly reverses the effects of an opioid overdose.

Narcan, a 4-milligram naloxone hydrochloride nasal spray, will not require a prescription and will be available in supermarkets, convenience and drug stores, gas stations, vending machines and online.

“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,” the FDA’s commissioner, Robert M. Califf, M.D., said in a statement.

“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.”

Manufacturer Emergent BioSolutions said Narcan, the standard treatment for opioid overdose, should be available over the counter by late summer.

Narcan blocks the effect that opioids have on the nervous system, reversing fatal overdoses.

Two nasal spray devices typically come in a single package. If a person is overdosing, the first Narcan dose should be administered before 911 is called. The person should get the second dose immediately after two to three minutes go by and they still are unresponsive.

The FDA will work with stakeholders to help make sure naloxone nasal spray is still available while the drug is switching over to OTC status.

“The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said. 

“Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions.”

The approval puts an end to a long battle by public health officials and addiction medication experts to make the life-saving drug more readily available. A panel of experts voted last month to increase access to try and prevent yet another year of deadly drug overdoses.

In November, the FDA said it was considering approving naxolone products to make it easier to access as an effort to fight the opioid crisis.

Opioids are currently the main cause of drug overdose deaths. In the United States in 2020, opioids were involved in 68,620 overdose deaths — 74.8% of all drug overdose deaths — according to the Centers for Diseases Control and Prevention.

“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,” Califf said.

Narcan nasal spray was approved by the FDA as a prescription drug in 2015. Those who are opioid dependent and who use the nasal spray may get severe opioid withdrawal symptoms such as body aches, diarrhea, increased heart rate, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.

“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” Cavazzoni said.