Butrans Pediatric Labeling Draws Mixed Views At US FDA Panel
Opponents say including data from a small pediatric trial of Purdue's buprenorphine patch could give the impression the study was more robust than it actually was, while supporters say labeling should reflect any available data that can inform pediatric prescribing.
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Incorporating data from two studies that raised safety and efficacy concerns would give a false sense of security about the drug’s use in pediatric patients, the panel majority said, while dissenters said some pediatric data in labeling is better than no information at all.
Keeping Track: Another Gene Therapy Approval, Several Priority Review Designations, And Many Resubmissions
The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA has updated the label for Purdue’s opioid pain therapy Butrans to note the existence of a pediatric study for the buprenorphine formulation. After consulting with its advisory committee, FDA didn’t include any further information.