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Emergent Expects Moving OTC Naloxone Directions On Package To Sway US FDA Advisory Panel

 
• By Malcolm Spicer

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.

• Source: Shutterstock

Emergent BioSolutions, Inc. will ask a US Food and Drug Administration advisory panel to agree that rearranging the placement of directions within labeling it tested for OTC use of its naloxone nasal spray will eliminate user errors which concern agency officials.

FDA officials, however, will explain at a joint meeting of the Nonprescription Drug and Anesthetic and Analgesic Drug Products advisory...

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