FDA approved Narcan, the brand name version of the drug manufactured by Emergent BioSolutions.
“FDA’s announcement to make Narcan available over-the-counter is an important step to make this medicine accessible to more people at a time when the majority of overdose deaths are being driven by illicit opioids like fentanyl,” said Rahul Gupta, Director of the White House Office of National Drug Control Policy.
Naloxone is a medicine that can help reduce opioid overdose deaths. When administered timely, usually within minutes of the first signs of an opioid overdose, it can counter the overdose effects.
Narcan is a nasal spray and requires no special training to administer, raising hopes from anti-opioid advocates that making it available over-the-counter will significantly broaden access.
The people who need naloxone the most are often the least likely to go to a pharmacy and request it because of the stigma surrounding drug use.
According to the manufacturer, Narcan will be available for retailers by late summer. The prescription product will remain available through pharmacies and through community distribution.
But the full impact of the FDA’s move will largely depend on how much Emergent charges. Harm reduction advocates have expressed concern that it could be priced out of reach for groups that distribute it to people who need it the most.
State governments and nonprofit agencies currently pay about $47 for a package that contains two spray canisters, each containing 4 milligrams of the drug.
Emergent has not said how much it will charge for the non-prescription version. While health insurance plans don’t typically cover over-the-counter drugs, advocates and experts are pressing to make that happen.
“All payers must continue or start to cover naloxone at no- or low-cost. There are many over-the-counter preventive health medications that are covered by insurance, such as aspirin, vitamin D, and fluoride. Naloxone should be added to that list,” Bobby Mukkamala, chair of the American Medical Association’s Substance Use and Pain Care Task Force, said in a statement.
