SILVER SPRING, MD.—In a 9-6 vote, two FDA advisory committees, which met in a joint meeting, recommended approval of Pfizer’s Troxyca ER, an oxycodone-naltrexone extended-release capsule with abuse-deterrent properties.
If approved, oxycodone-naltrexone would be indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
The panel also recommended that the product, if approved, be labeled as offering abuse deterrence for nasal and