What is Xtampza ER (oxycodone extended-release)?

From the Guidelines

Xtampza ER is a prescription opioid pain medication containing oxycodone in an extended-release formulation, used to manage severe pain that requires around-the-clock, long-term treatment when other pain medications are inadequate, as recommended by the CDC clinical practice guideline for prescribing opioids for pain - United States, 2022 1.

Key Characteristics of Xtampza ER

• Xtampza ER works by slowly releasing oxycodone over time, providing continuous pain relief for 12 hours per dose.
• It has a unique abuse-deterrent formulation designed to maintain its extended-release properties even if the capsule is crushed or chewed.
• The medication should always be taken with food to ensure proper absorption and consistent pain relief.

Important Considerations for Use

• Common side effects include constipation, nausea, drowsiness, and dizziness.
• As a Schedule II controlled substance, Xtampza ER carries risks of addiction, abuse, and misuse, even at recommended doses, and should be used exactly as prescribed.
• Patients should never adjust their dose without consulting their healthcare provider and should be aware that stopping the medication abruptly can cause withdrawal symptoms.

Clinical Guidelines for Prescribing Xtampza ER

• According to the CDC guideline, ER/LA opioids like Xtampza ER should be reserved for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment when alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain 1.
• Clinicians should not treat acute pain with ER/LA opioids or initiate opioid treatment for subacute or chronic pain with ER/LA opioids, and should not prescribe ER/LA opioids for intermittent use 1.
• The FDA has noted that some ER/LA opioids are only appropriate for opioid-tolerant patients, defined as patients who have received certain dosages of opioids for at least 1 week 1.

From the Research

Definition and Approval of Xtampza ER

• Xtampza ER (oxycodone extended-release) is an abuse-deterrent formulation of oxycodone as the myristate salt, approved in the USA 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 2.
• It is designed to provide safe and effective pain relief to treat pain severe enough to require around-the-clock, long-term dosing 3.

Mechanism and Properties

• The microsphere-in-capsule DETERx ® drug delivery platform allows administration via sprinkle-dosing or enteral tubes 2.
• The physicochemical properties of the formulation make it difficult to manipulate and its ER pharmacokinetic profile is retained after crushing or chewing 2, 4, 3.
• The formulation contains microspheres that combine oxycodone with inactive ingredients to increase the difficulty of tampering with the ER mechanism 4.

Efficacy and Tolerability

• The efficacy of oxycodone DETERx ® ER in the management of moderate to severe, chronic pain was demonstrated in a well-designed, phase III trial, in which it was more effective than placebo at reducing pain intensity 2, 5.
• The formulation was generally well tolerated in this trial; the most common treatment-emergent adverse events were nausea and constipation 2, 5.
• Xtampza ER resulted in clinically and statistically significant efficacy in patients with chronic low back pain 5.

Abuse-Deterrent Properties

• Clinical abuse-potential studies suggest that the properties of Xtampza ER may translate to reduced intranasal abuse, with implications for abuse via the oral route less certain 2.
• Human abuse-potential studies conducted in a population of recreational opioid users demonstrated lower drug-liking scores for oxycodone DETERx administered intranasally and orally when compared with IR oxycodone 3.
• The retention of ER PK properties when capsule contents are physically manipulated before oral administration suggests Xtampza ER has lower potential to be manipulated for oral abuse when compared with IR oxycodone or OxyContin 4.