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Drivers For Allowing OTC Naloxone In US Include Social Justice As Well As Public Health Need

Executive Summary

Communities where opioid overdoses are highest “are less likely to have a physician who can order naloxone for them,” says researcher Nabarun Dasgupta. Naloxone switch developer Michael Hufford says “disconnects” with FDA “continue to hamper and delay OTC naloxone product applications.”

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US FDA Expects No Change In Naloxone Access Barrier If Prices High For Potential OTC Products

FDA and non-profit firm Harm Reduction Therapeutics head Michael Hufford agree consumers could pay more out-of-pocket for OTC product than they do in co-pays for insurance plans. But Hufford says consumers’ costs for HRT’s OTC naloxone product won’t be impediment to expanding access.

OTC Naloxone NDA In US Gets Fast Track Status

Nonprofit HRT reached a commercial supply agreement for a firm to produce its RiVive naloxone nasal spray still in development after FDA granted fast frack designation for its OTC switch NDA.

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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