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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Harm Reduction Therapeutics submits NDA for OTC approval of a 3-mg naloxone nasal spray branded RiVive. CEO Michael Hufford says the NDA touches all the bases FDA detailed in notice it published on what’s needed in naloxone OTC switch proposals.
Naloxone Switch NDA Submitted As US FDA Signals Nonprescription Access Looks Safe, Effective
Harm Reduction Therapeutics submits NDA for OTC approval of a 3-mg naloxone nasal spray branded RiVive. CEO Michael Hufford says the NDA touches all the bases FDA detailed in notice it published on what’s needed in naloxone OTC switch proposals.
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.