Harm Reduction Therapeutics Inc. clears a major hurdle to submitting a US proposal for an OTC naloxone nasal spray with up to $6.5m made available in Purdue Pharma LP’s bankruptcy proceeding to pay for a Phase 1 study of the product.
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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HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.
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“I’m not sure exactly if they understood how broad this actually is and what that might potentially lead to or what the follow-up would be if somebody now decides to sell a 10-milligram version of ivermectin for human use,” says food and drug regulation attorney Frederick Stearns.