HRT Reports 'Remarkable Achievement' In OTC Naloxone Phase 1 Clinical Trial Results
Harm Reduction Therapeutics CEO Michael Hufford says non-profit is “rapidly moving forward” with OTC naloxone NDA.
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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.
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.
Financial model is not adequate right now, FDA Commissioner Robert Califf says, so the agency may make regulatory changes to motivate sponsors.