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Anesthetic and Analgesic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee

On Thursday, September 14, 2017, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSRM) discussed a supplemental new drug application (sNDA) for Butrans (buprenorphine transdermal system, BTDS) submitted by Purdue Pharma L.P. (Purdue), evaluating Butrans in pediatric patients aged 7 through 16 years for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The Committees were specially asked to discuss the findings of the clinical study of Butrans conducted in pediatric patients, and whether they support additional labeling.