The FDA approved selling naloxone over-the-counter, marking the first time an opioid treatment drug will be available without prescription.
The Food and Drug Administration on Wednesday approved selling the overdose-reversal drug Narcan without a prescription, a move long sought by advocates to improve access to the life-saving drug.
The approval would make the nasal spray used to counteract fentanyl and opioid overdoses more accessible to consumers who could buy the medication at stores without a prescription or pharmacist’s recommendation. Florida has allowed Narcan to be sold at pharmacies since 2016 but only after talking to a pharmacist.
FDA Commissioner Robert Califf urged the drug’s manufacturer to make Narcan widely available at an affordable 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,“ Califf said in a statement.
Here’s what you need to know.
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Narcan is the brand name of naloxone, an „opioid antagonist.“
It can quickly reverse overdoses of opioids, including street drugs such as heroin and fentanyl and prescription versions including oxycodone. Narcan is easy to administer as a nasal spray, advocates say, but it is also available as an injection. It can begin to work within a few minutes, though multiple doses may be needed.
Narcan can be administered by someone who is not a healthcare professional before paramedics arrive but it is not intended as a substitute. It is safe to administer even if a person is not suffering from an opioid overdose.
Making naloxone available more widely is seen as a key strategy to control the nationwide overdose crisis, which has been linked to more than 100,000 U.S. deaths a year. The majority of those deaths are tied to opioids, primarily illicitly manufactured fentanyl that can take multiple doses of naloxone to reverse.
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Advocates believe it’s important to get naloxone to the people who are most likely to be around overdoses, including people who use drugs and their relatives.
The approved branded nasal spray from Gaithersburg, Maryland-based Emergent BioSolutions is the best-known form of naloxone.
