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Is Xtampza ER a controlled substance?

Medically reviewed by Judith Stewart, BPharm. Last updated on Feb 13, 2023.

Official answer


Yes. Xtampza ER (oxycodone) is a schedule II controlled substance.

What is Xtampza ER?

Xtampza ER (oxycodone) an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Xtampza ER is an extended-release, abuse-deterrent formulation of oxycodone for twice-daily administration.

What is a Schedule II Controlled Substance?

Drugs placed in Schedule II of the Controlled Substances Act (CSA) have a high potential for abuse and dependence.

Drugs in Schedule II have a currently accepted medical use in the United States or a currently accepted medical use with severe restrictions. Abuse of these drugs may lead to severe psychological or physical dependence.

Examples of Schedule II substances include morphine, cocaine, hydrocodone, oxycodone, fentanyl, and methylphenidate.

What does Abuse-Deterrent mean?

Xtampza ER uses the proprietary DETERx® technology platform to prevent abuse of the active ingredient oxycodone. It is designed to prevent abuse by maintaining the drug release profile even after physical manipulation including chewing and crushing/dissolving. Misuse of Xtampza ER can lead to overdose and death.

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