The FDA has approved Xtampza ER extended-release capsules, CII, 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.
The FDA has approved Xtampza ER (oxycodone; by Collegium Pharmaceutical) extended-release capsules, CII, 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. The approval carries the limitation that because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release formulations, Xtampza ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient pain management. Another limitation is that Xtampza ER is not indicated as an as-needed analgesic.1,2 Xtampza ER utilizes Collegium’s proprietary DETERx technology, which provides adequate pain control while maintaining its drug release profile after common means of manipulation, including chewing or crushing.2
Pharmacology and Pharmacokinetics
Xtampza ER is a full-opioid agonist with relative selectivity for the mu receptor, although it can bind to other opioid receptors at higher doses. Its principal therapeutic action is analgesia.
Xtampza ER is not bioequivalent to oxycodone extended-release tablets. Its formulation is designed to provide oxycodone delivery over 12 hours.1
Dosage and Administration
A total daily Xtampza ER dose higher than 72 mg (equivalent to 80 mg of oxycodone HCl) or a single dose higher than 36 mg (equivalent to 40 mg oxycodone HCl) should only be used in patients with established opioid tolerance. Opioid-naive and opioid-nontolerant patients should begin treatment with 9 mg (equivalent to 10 mg oxycodone HCl) orally every 12 hours with food. Patients with hepatic impairment should initiate treatment at one-third to one-half the usual dose; patients requiring less than 9 mg should use an alternate medication. Xtampza ER should not be abruptly discontinued in a patient who is physically dependent. The capsules may be opened and sprinkled onto soft food. The maximum total daily dose is 288 mg (equivalent to 320 mg oxycodone HCl).1
Xtampza ER was evaluated in an enriched-enrollment, randomized-withdrawal, double-blind, placebo-controlled, parallel group study of 740 patients with persistent, moderate to severe chronic lower back pain with inadequate pain control from their previous medication. Patients were randomized to either Xtampza ER or placebo. At 12 weeks, a significant reduction in pain was found in the group using Xtampza ER.1
Contraindications, Warnings, and Precautions
Xtampza ER carries a boxed warning that its use exposes patients to risks of addiction, abuse, and misuse, which can lead to overdose and death. Serious, life-threatening or fatal respiratory depression may occur. Accidental ingestion of Xtampza ER, especially by children, can result in a fatal overdose of oxycodone. Prolonged use of Xtampza ER during pregnancy can result in neonatal opioid withdrawal syndrome. Use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of oxycodone.
Xtampza ER is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, known or suspected gastrointestinal obstruction, including paralytic ileus, or hypersensitivity to oxycodone.
If adrenal insufficiency is diagnosed, it should be treated with physiologic replacement and Xtampza ER should be tapered and discontinued. Patients should be monitored for hypotension when beginning Xtampza ER. It should not be used in patients with circulatory shock, impaired consciousness, or coma.
Concurrent use of Xtampza ER with central nervous system depressants may lead to profound sedation, respiratory depression, coma, and death. Concomitant use with serotonergic drugs may cause serotonin syndrome. Xtampza ER should not be used in conjunction with mixed- agonist/antagonist and partial-agonist opioid analgesics.
Patients should not breast-feed while using Xtampza ER. Geriatric patients should initiate treatment with a low dose and be monitored closely for respiratory depression.
The most common adverse reactions (>5% incidence) are nausea, headache, constipation, somnolence, pruritus, vomiting, and dizziness.1
Dr. Holmberg earned her PharmD from the University of Connecticut and completed an ambulatory care residency at the Phoenix VA Healthcare System. Her practice has also included pediatrics and inpatient mental health. She resides in Phoenix, Arizona.
- Xtampza ER [package insert]. El Segundo, CA: Collegium Pharmaceutical; April 2016.
- Collegium receives FDA approval for Xtampza ER, an analgesic with abuse-deterrent properties for the treatment of chronic pain [press release]. Collegium Pharmaceutical website. ir.collegiumpharma.com/phoenix.zhtml?c=253995&p=irol-newsArticle&ID=2161728. Accessed August 2016.