FDA underscored its interest in proposals for allowing OTC access to naloxone for treating opioid overdose by taking the unprecedented step of developing model Drug Facts labels that potential sponsors can use for their own label comprehension studies.
The agency announced the release of the model DFLs on Jan. 17 along with publication of its review of independent research contractors' study of label comprehension for OTC use of nasal spray and auto-injector products, the two forms of naloxone currently available Rx-only "in consumer-friendly format." The contractors used a prespecified research design with more than 700 participants across a range of potential OTC naloxone users with separate DFLs for a
In FDA's announcement, Commissioner Scott Gottlieb said agency staff concluded that the study showed the model DFLs, which include pictorials separate from the text, demonstrating how to administer either the nasal spray or injector, were well-understood by consumers and are