Purdue's Butrans: US FDA Panel To Consider Pediatric Labeling, But Not A New Indication

16 Aug 2017

• By Michael Cipriano

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.

The US FDA is convening its Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to evaluate pediatric data for Purdue Pharma LP's partial opioid agonist Butrans (buprenorphine), but the company is not seeking to market the drug for children.

FDA announced plans for the Sept. 14 meeting in a notice published in the Aug. 16 Federal Register. The joint...