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.

Harm Reduction Therapeutics Inc.’s new drug application for OTC naloxone has received fast track designation after the US Food and Drug Administration initially denied its request concerning its intranasal spray for opioid overdose emergency treatment.

The Pittsburgh-based nonprofit launched in 2017 to develop naloxone that would be available OTC free or at low-cost told HBW...