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FDA's OTC Naloxone Model Labels Confirmed In CONFER Study

 
• By Malcolm Spicer

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.

A study of making naloxone available OTC study supports model Drug Fact labels FDA designed even though agency officials noted concern that some participants didn't meet a "clinically critical endpoint" of contacting emergency services immediately after administering the opioid-overdose treatment.

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