The Food and Drug Administration (FDA) has approved sales without a prescription of the nasal spray Narcan to reverse opioid overdoses, a decision that promises to significantly expand access to the lifesaving treatment.
The FDA’s decision means people will be able to buy the 4 milligram nasal spray in supermarkets, convenience stores, gas stations, vending machines and online. Emergent BioSolutions, the manufacturer, has said Narcan should be available without a prescription by late summer.
Narcan reverses fatal overdoses by blocking the effect that opioids have on the nervous system. The nasal spray must be administered as soon as an overdose is suspected.
The FDA said in November that it was considering approving naloxone products, the generic name for medications that reverse opioid overdoses, for use without a prescription. The push to make naloxone easier to access is part of the FDA’s efforts to fight the opioid crisis.
More than 564,000 people died from opioid overdoses between 1999 and 2020, according to the Centers for Disease Control and Prevention. The first wave of the epidemic began in the 1990s with prescription opioids, followed by an increase in deaths from heroin starting in 2010.
Two nasal spray devices typically come in a single package. The first dose should be administered in one nostril of the person suffering an overdose and then 911 should be called, according to the instructions.
If the person is still unresponsive after two to three minutes, the second dose should be administered.
Deaths from synthetic opioids such as fentanyl have increased significantly since 2013. More than 71,000 people died from synthetic opioids in 2021, a 18% increase over the year prior.
The opioid epidemic was declared a public health emergency in 2017. The emergency has since been renewed every 90 days.
In a statement, FDA Commissioner Dr. Robert Califf said the agency is encouraging the company to make the nasal spray as widely available as possible at an affordable price.