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# FDA OKs Expanded Abuse Deterrent Claims for Xtampza
- URL: https://www.fdaweb.com/fda-oks-expanded-abuse-deterrent-claims-for-xtampza/
- Published: 2017-11-08T12:00:00.000Z
- Updated: 2026-09-14T23:00:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140087

FDA has approved a Collegium Pharmaceutical supplemental NDA to enhance the label for Xtampza ER (oxycodone extended-release), an abuse-deterrent, extended-release opioid, for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The sNDA approval, according to the company, permits the following three main changes: 

- OxyContin Comparative Data — The addition of comparative oral pharmacokinetic data, collected in two completed clinical studies evaluating the effect of physical manipulation by crushing Xtampza ER compared with the abuse-deterrent version of OxyContin (oxycodone hydrochloride extended-release tablets) and a control (oxycodone immediate-release).
- Oral Human Abuse Potential Study — Results of an oral human abuse potential study comparing intact and manipulated Xtampza ER to oxycodone IR were added to the label. This study demonstrated that the oral administration of chewed and intact Xtampza ER in the fasted state was associated with statistically lower mean Drug Liking and Take Drug Again Visual Analog Scale scores compared with crushed immediate-release oxycodone.
- Oral Abuse Deterrent Claim — The addition of an oral abuse deterrent claim on the label that indicates that Xtampza ER has physicochemical properties that are expected to reduce abuse via the oral route. Xtampza ER is the only single agent oxycodone with this labeling.