FDA Advisory Committees Recommend Pfizer’s Troxyca

Two FDA advisory committees backed the approval of Pfizer’s opioid Troxyca for severe pain management when alternative treatments are inadequate with abuse-deterrent labeling for nasal and intravenous routes.

The committees voted 9-6 for the approval of the extended-release opioid. Committee members said the product met current standards of approval for opioids. Those who voted against its approval suggested it would be counterintuitive to put another opioid on the market in the face of an opioid epidemic.

The Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee voiced similar concerns last week after it recommended approval of Teva Pharmaceutical’s Vantrela extended-release opioid for the same indication with abuse-deterrent labeling for oral, nasal and intravenous routes.