The Food and Drug Administration aims to conduct priority reviews of at least two product applications for granting over-the-counter status to intranasal formulations of naloxone, an overdose-reversal drug.
Naloxone prevents overdose deaths by binding to opioid receptors in the brain and blocking entry to competing opioids, or pushing them aside. The drug is sold in three versions: vials of injectable naloxone, auto-injectors (similar to EPIPENs) and as an intranasal spray.
In response to the announcements, harm reductionists — including some of the staunchest proponents of this regulatory shift — are raising concerns that the effort won’t be enough to improve access for the people most vulnerable to overdose. It’s true that granting OTC status to intranasal naloxone is, on its own, an inadequate solution to the dearth of this life-saving medication in communities across the country. But it is still worth fighting for, and it can be an important and incremental step toward curbing overdose deaths.
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