OTC Naloxone In US: Once Encouraged, Now Stalled

FDA, in unprecedented step, in 2018 published a model DFL for an OTC naloxone nasal spray developed in a study it sponsored, and former FDA Commissioner Scott Gottlieb noted a need for OTC naloxone. Four years later, US remains without OTC naloxone.

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Young boys or girls in the US can buy enough acetaminophen at grocery stores to cause severe damage to internal organs and potentially death if used unsafely, but they can’t purchase a drug which has no abuse potential while preventing opioid overdose deaths.

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