FDA Approves Over-the-Counter Naloxone Nasal Spray, Expected to Reduce Opioid Overdose Deaths Throughout the US

The US Food and Drug Administration (FDA) has approved an over-the-counter version of the opioid overdose reversal drug naloxone, a move that is expected to increase access to the lifesaving medication and reduce opioid overdose deaths throughout the country.

The FDA Commissioner Dr. Robert Califf said in a statement that the agency has used its regulatory authority to facilitate greater access to naloxone. The drug, sold by drugmaker Emergent BioSolutions under the brand name Narcan, was previously only available in the United States as a prescription drug.

Dr. Scott Hadland, a pediatrician and an addiction specialist at MassGeneral Hospital for Children in Boston, said that making the drug available over the counter could save more lives. He added that the FDA remains committed to addressing the evolving complexities of the overdose crisis.

The approval of the OTC naloxone nasal spray is expected to improve access to the drug, increase the number of locations where it’s available, and help reduce opioid overdose deaths throughout the country. It is also expected to provide an additional option for those who may not have access to a prescription or a pharmacy.

The FDA has taken steps to make naloxone more widely available in recent years, including approving a generic version of the drug and allowing it to be sold in pharmacies without a prescription in some states. The approval of the OTC version of the drug is the latest step in the agency’s efforts to reduce opioid overdose deaths.