Ohio Study Shows Access To Naloxone Soars Without Rx Requirement
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.
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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.
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.
Development of the model DFLs was a first for agency, reflecting alarm over public health crisis of overdoses from opioid abuse, which reached nearly 48,000 in 2017. The project was "part of our broader commitment to addressing the opioid crisis" and should help sponsors with potential naloxone OTC switch NDAs, says Commissioner Scott Gottlieb.