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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Testing results for subjects who wore face masks before and after intranasal administration suggest early absorption of naloxone was adversely affected. Expanding Access to Affordable Prescription Drugs and Medical Devices Act would provide support for nonprofits such as Harm Reduction Therapeutics, which continues research for an NDA for an OTC naloxone nasal spray.
JAMA study finds that removing Rx requirement for naloxone in Ohio resulted in a 2,328% increase in orders of the drug dispensed since 2015. Michael Hufford, CEO of a company working on an OTC switch for a naloxone nasal spray, says the results show urgent need for a low-cost OTC product.
Bankrupt Purdue proposes continued funding for developing OTC naloxone product through firm to sell ‘millions of doses’ of the emergency opioid overdose product at low or no cost. Harm Reduction Therapeutics, which previously received funding from Purdue, has pushed back target date for NDA until early 2021 for its OTC naloxone nasal spray.