OTC Naloxone Nasal Spray Biocompatibility Study Funded In US From Purdue Pharma Bankruptcy
Up to $6.5m funding will completely cover Harm Reduction Therapeutics' costs for a Phase 1 study, preparation of an NDA and commercial launch production. The study, a standard Phase 1 biocompatibility trial with around 30 subjects, should be completed in a few months later this summer.
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Financial model is not adequate right now, FDA Commissioner Robert Califf says, so the agency may make regulatory changes to motivate sponsors.
Financial model isn't adequate currently, FDA Commissioner Robert Califf says, and agency may make regulatory changes to motivate sponsors.
Harm Reduction Therapeutics CEO Michael Hufford says non-profit is “rapidly moving forward” with OTC naloxone NDA.