Naloxone OTC Switch Application On Horizon Thanks To $3.4M Funding From Purdue
This article was originally published in The Pink Sheet & The Rose Sheet
Harm Reduction Therapeutics, which has sought funding for a US Rx-to-OTC new drug application, receives grant from Purdue Pharma that enables filing and launching the product in a targeted 100,000 retail locations within two years.
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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.
FDA appears committed to stemming opioid abuse by accelerating reviews of ANDAs for generics of overdose treatments but acceleration for making one of them, naloxone, available OTC is needed, too, says Michael Hufford, Harm Reduction Therapeutics CEO. "Relief that ... FDA is demonstrating its willingness to do everything that it can to accelerate these approvals," but "frustration that the public continues to be denied access to low cost naloxone," he says.