Collegium Petitions FDA for Curbs on Oxycodone

Collegium Pharmaceutical has petitioned FDA for a block on other extended-release oxycodone drug products unless they bear abuse-deterrent labeling based on premarket studies. Earlier this year, the agency approved the company’s NDA for Xtampza ER (oxycodone) extended-release capsules with abuse-deterrent labeling based on premarket studies identified in FDA’s Abuse-Deterrence Guidance.

Xtampza uses the company’s proprietary DETERx technology platform, which Collegium says is designed to provide adequate pain control while maintaining its drug release profile after being subjected to common methods of manipulation, including product chewing and crushing prior to administration. The drug’s label also contains information supporting administration by sprinkling the capsule contents on soft foods or into a cup, and then directly into the mouth, or through a gastrostomy or nasogastric feeding tube.