1. HBW Insight
  2. >>Health
  3. >>Rx-to-OTC Switch

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.

On Jan. 17, FDA published a report on agency staff's review of independent research contractors' study of label comprehension for OTC use of nasal spray and auto-injector products, Comprehension for...

More from Rx-to-OTC Switch

More from Health

IQVIA Consumer Health: Digestive Category Driving Global OTC Market Growth

 
• By David Ridley

An increasing awareness of and interest in gut health helped the global OTC market grow by 4.6% in value terms in 2024, according to IQVIA Consumer Health.

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

Alliance Pharma’s New Owners Will Instill ‘More Consumer-Oriented Mindset’

 
• By Tom Gallen

Private equity firms now in control of Alliance Pharma weighing úp plan to offload Rx business to help finance strategy to drive up sales and growth.