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HRT Reports 'Remarkable Achievement' In OTC Naloxone Phase 1 Clinical Trial Results

Executive Summary

Harm Reduction Therapeutics CEO Michael Hufford says non-profit is “rapidly moving forward” with OTC naloxone NDA.

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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.

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.

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