Pediatric Opioid Development Faces Grim Outlook After Advisory Cmte.
Panelists appeared to have more questions than answers as the common cliché of 'more research is needed' dominated the two-day meeting.
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Endo seeks to add findings from two open-label pediatric studies to labeling for its immediate-release opioid analgesic but is not seeking a pediatric use indication; advisory committee also will consider whether something more than routine pediatric safety monitoring is needed for Purdue’s OxyContin, which added a pediatric indication in 2015.
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.
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.