Urgency For Approval Of OTC Naloxone In US Weighed Against Using Untested Package Labeling
All members of a joint advisory panel noted an urgent need to expand naloxone access and voted yes on OTC sales of Emergent's Narcan nasal spray, but many also raised concerns about the testing needed for the DFl Facts label the firm unveiled during the meeting.
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Based on results from its study for switch NDA, with primary endpoint of users’ success in administering naloxone nasal spray, Emergent changes which DFl panels include the directions. FDA will tell advisory committee the firm has no study data validating effectiveness of changes.
CDER will ask advisory panel “whether additional labeling information might mitigate risk of use errors” for Emergent’s naloxone nasal spray made available OTC and whether results of firm’s human factors study “support that consumers are able to correctly administer nonprescription [naloxone nasal spray] in an emergency situation.”