The FDA has approved the over-the-counter sale of naloxone nasal spray, a medication that can rapidly reverse the effect of opioid overdose, making the current lifesaving standard treatment available widely and more affordable.
FDA approves opioid overdose medicine for use without a prescription
The US Food and Drug Administration (FDA) has taken the bold step of approving Narcan (naloxone hydrochloride), a drug that is the current standard treatment for opioid overdoses, to be available without a prescription.
Specifically, the FDA approved the use of Narcan, the 4-milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription. It is the first naloxone product approved for use without a prescription.
The FDA’s action will allow the direct sale of an opioid overdose antidote in drug stores, grocery stores, convenience stores, restaurants, gas stations, online, and more.
How soon the nasal spray will be available and the price of the OTC product will be determined by the manufacturer, the FDA said in a press release.
The drug manufacturer of Narcan is Emergent BioSolutions.
“Today’s landmark FDA OTC approval for Narcan Nasal Spray marks a historic milestone as 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,” Emergent BioSolutions CEO Robert G. Kramer said in a statement, NPR reported.
Move prompted by rising deaths from illicit opioids
The move comes as drug overdose deaths in the United States continue at staggering near record levels, CNN reported. The director of the White House’s National Drug Control Policy, Dr. Rahul Gupta, said accessibility will be the key to ensuring that the Narcan nasal spray saves lives.
“It’s really important that we continue to do everything possible in our power to make this life-saving drug available to anyone and everyone across the country,” Dr. Gupta said.
The epidemic of drug overdoses continues to rise in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022. The primary driver of opioid overdoses is illegal, synthetic opioids such as fentanyl, according to the FDA.
“The FDA remains committed to addressing the evolving complexities of the overdose crisis,” FDA Commissioner Robert M. Califf, M.D., said in a statement. “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.”
“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,” Dr. Califf continued. “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.”