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.
You may also be interested in...
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.
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.”
Harm Reduction Therapeutics CEO Michael Hufford says non-profit is “rapidly moving forward” with OTC naloxone NDA.