FDA labeling study helps clear path for OTC naloxone

FDA labeling study helps clear path for OTC naloxone

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RAPS.org
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Consumers reading a model drug facts label for naloxone could understand labeling sufficiently to use the opioid antagonist safely and effectively without the support of a healthcare provider, according to a label-comprehension study conducted by the US Food and Drug Administration (FDA).

The unusual move by the FDA could help clear a hurdle to approval of over-the-counter injectable and intranasal naloxone; many public health experts concerned about the impact of the opioid crisis have called for wide access to the potentially life-saving drug. Naloxone rapidly reverses many of the signs and symptoms of opioid overdose, especially life-threatening respiratory depression, and may safely be given repeatedly during overdose treatment.