Purdue's Butrans: US FDA Panel To Consider Pediatric Labeling, But Not A New Indication
Purdue says it conducted a trial required under the Pediatric Research Equity Act but is not seeking a formal indication and will not promote the opioid for pediatric populations. Two advisory committees will discuss the trial results and whether they support additional labeling for the buprenorphine transdermal product Sept. 14.
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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.
Advisory committees will discuss whether data from a 41-patient study should be added to Pediatric Use section of labeling for Purdue's buprenorphine product; agency's decision to convene expert panel even though a pediatric indication is not being considered grew out of criticism generated by approval of OxyContin for adolescents.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.