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Naloxone approved for sale without a prescription


FDA decision comes as nation battles rising deaths from opioid addiction

Naloxone, the standard treatment for opioid overdose, will soon be available for sale without a prescription in the form of a nasal spray.

On March 29 the Food and Drug Administration (FDA) approved the sale of Narcan, a 4-milligram hydrochloride naloxone nasal spray, for over-the-counter (OTC) nonprescription use.

“Today’s action paves the way for life-saving medication to reverse an opioid overdose to be sold directly to consumers,” the agency said in a news release. Sale locations will include drug stores, convenience stores, grocery stores, gas stations, as well as 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,” said FDA Commissioner Robert M. Califf, M.D.

While the price and timing for Narcan’s OTC availability will be determined by its producer, Emergent BioSolutions, Califf said the FDA will encourage the company to make it available as quickly as possible and at an affordable price. In the meantime, the agency will work to ensure the continued availability of naloxone nasal spray during the time needed to switch Narcan from prescription to OTC status.

A statement from Emergent BioSolutions chief executive officer Robert G. Kramer did not address price or the timing of availability. “We are dedicated to improving public health and assisting those working hard to end the opioid crisis — so now with leaders across government, retail and advocacy groups, we must work together to continue increasing access and availability, as well as educate the public on the risks of opioid overdoses and the value of being prepared with Narcan to help save a life,” Kramer said.

The decision to allow OTC naloxone sales comes as the nation faces a mounting death toll from opioid overdoses. According to the FDA, more than 101,750 fatal overdoses occurred just during the 12-month period ending in October 2022. Since 1999 overdose deaths involving opioids have increased by more than eight times according to the Centers for Disease Control and Prevention.

The FDA first approved the sale of Narcan nasal spray by prescription in 2015. As opioid-related deaths continued to mount, the agency granted priority review status to the application to approve Narcan nasal spray for OTC. At a February 2023 meeting, advisory committee members voted unanimously to recommend approval for marketing without a prescription.

Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, called naloxone a “critical tool in addressing opioid overdoses,” adding that the approval “underscores the extensive efforts the agency has undertaken to combat the overdose crisis.

The FDA says approving OTC Narcan nasal spray will require changing the labeling for the currently approved 4-mg naloxone spray products that use Narcan as their reference listed drug product. Current manufacturers of these products will have to submit supplements to their applications to switch their products 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, Cavazzoni 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.”

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