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# FDA Calls Xtampza ER Booth False, Misleading
- URL: https://www.fdaweb.com/fda-calls-xtampza-er-booth-false-misleading/
- Published: 2018-02-21T12:00:00.000Z
- Updated: 2026-09-14T23:24:08.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140816

The CDER Office of Prescription Drug Promotion (OPDP) says a Collegium Pharmaceutical exhibit booth for its Xtampza ER (oxycodone) extended-release capsules for oral use made false or misleading representations because it failed to adequately communicate information about the serious risks associated with the drug’s use. A 2/9 [Notice of Violation](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM597584.pdf?ref=fdaweb.com) says Xtampza ER is indicated for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate.

The drug labeling contains Boxed Warnings about addiction, abuse, misuse, life-threatening respiratory depression, accidental ingestion, neonatal opioid withdrawal syndrome, and risk from concomitant use with benzodiazepines or other central nervous system depressants.

The notice says that the OPDP advisory comments 9/9/16 addressed draft Collegium presentations for the drug with certain similarities to the exhibit booth. It says the booth made representations and/or suggestions about Xtampza ER but failed to adequately provide material information about the drug’s limitations of use and the serious and life-threatening consequences that may result from the use of the drug, thereby creating a misleading impression about the drug’s safety.

Collegium was told to stop using violative promotional materials and to respond with a list of all promotional materials containing statements such as those described in the notice and its plan for discontinuing such violative promotion.