FDA approves first over-the-counter version of opioid overdose antidote Narcan
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US Food and Drug Admin. Approves Over-the-Counter Narcan
Last updated Mar 29, 2023
Image credit: wsjFacts
- On Wednesday, the US Food and Drug Administration (FDA) approved Narcan, a drug used to reverse the effects of an opioid overdose, for over-the-counter use.[1]
- The move makes Narcan the first naloxone-based drug to be purchased without a prescription and will align the federal government's stance with states that already offer Narcan at pharmacies without a prescription.[2]
- Until now, Narcan has only been available as a prescription drug in the US, though some states have allowed people to get the drug directly from pharmacists, community centers, local health departments, and needle exchange programs.[3]
- An FDA advisory committee voted unanimously last month to approve Narcan for over-the-counter sales without a prescription. The 4-milligram naloxone hydrochloride nasal spray was the specific dosage approved, and other formulations and dosages of the drug will still need a prescription.[4]
- The drug’s maker, Emergent BioSolutions, says it is expected to be available for purchase in stores and online by late summer.[5]
- Drug overdoses have created a public health crisis in the US, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022. This was largely caused by synthetic opioids like fentanyl.[6]
Spin
Pro-establishment narrative
This approval of the over-the-counter availability of Narcan will help improve access to this life-saving drug, increase the number of locations where it can be accessed, and help reduce opioid overdose deaths throughout the country. The opioid crisis is devastating the US, and this move is an important starting place for getting people quality treatment for substance use disorders.
Establishment-critical narrative
While this is an important step toward addressing the opioid crisis in the US, many barriers to access may still exist for individuals experiencing drug addiction. If the cost of over-the-counter Narcan is too high, as it has been previously, many people will still not be able to access this life-saving drug.
