FDA's OTC Naloxone Model Labels Confirmed In CONFER Study
Participants in FDA-commissioned CONFER study were scored on following label instructions for checking whether a potential patient has overdosed and administering a naloxone dose before calling for emergency help as well as on a "composite of cognitive walkthrough" of all those steps. Participants were in four groups: adult users of heroin and prescription opioids; those persons' friends and family members 18 years old and up; and separate groups of volunteers, 15- to 17-year-olds and adults.
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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.
Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.
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.