Nonprescription Naloxone Nasal Spray Receives FDA Approval (1)

Emergent BioSolution’s opioid overdose reversal drug Narcan will be available without a prescription for the first time, in a move that aims to increase access to a lifesaving medication during the opioid crisis but raises concerns about costs.

The Food and Drug Administration announced Wednesday it’s approved a 4-milligram version of a naloxone hydrochloride nasal spray, which is sold by Emergent under the brand name Narcan, marking the first time nalaxone has been made available as an over-the-counter drug. The decision culminates a multiyear effort by the agency to combat the growing drug overdose crisis, which is now largely driven by synthetic opioids such as fentanyl. Drug overdose deaths killed more than 93,000 people in 2020 in the US.

“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,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “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. 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.”

Robert G. Kramer, president and CEO of Emergent BioSolutions, called the over-the-counter approval a historic milestone “to make their opioid overdose reversal widely available. “We have delivered on our commitment to make this important emergency treatment widely accessible, given the alarming rates of opioid overdoses occurring across the country.”

However, there have been concerns about how Emergent will price their over-the-counter medication, and whether the drug will be affordable without insurance co-pays. A multi-step nasal spray costs about $85 and a single-step nasal spray costs about $150, according to the New York City health department. A spokesperson for Emergent said Wednesday there’s “nothing new to share on price at the moment.”

FDA Commissioner Robert M. Califf called for the company to make Nalaxone affordable, an unusual step for an agency that doesn’t typically weigh in on price. “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,” Califf said.

Kramer said Emergent is dedicated to working with leaders across government, retail, and advocacy groups “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® Nasal Spray.”

—With assistance from Tanaz Meghjani of Bloomberg News and Bloomberg Law Automation.