New Pain Med Approved: Xartemis XR

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Xartemis XR (oxycodone/acetaminophen) extended release tablets were approved by the FDA on March 12, 2014. It is the first and only extended-release combination controlled substance approved for acute pain severe enough to require opioid treatment, where other treatment options have not worked.

How does Xartemis XR work?
Xartemis XR contains BOTH immediate and extended-release release components. This provides pain relief within 1 hour of taking the medication, and allows for twice-daily dosing.

What strengths are available, and how should it be taken?
Xartemis XR is available in only one strength, as an extended-release tablet with 7.5 mg of oxycodone and 325 mg of acetaminophen. Dosing is typically 2 tablets given twice daily.

When will this medication be available to patients?

According to the manufacturer, this medication was shipped to suppliers on March 20, 2014, so it should be available in pharmacies shortly.

Does Xartemis XR contain an abuse deterrent?

NO. However, the manufacturer, Mallinckrodt, has stated that they will continue to work with the FDA to develop abuse deterrent features for it in the future.

What type of extended-release delivery system does Xartemis XR use?
Xartemis XR uses Depomed’s Acuform drug delivery technology. Acuform delivery allows for targeted, controlled delivery of Xartemis XR into the upper gastrointestinal tract—a preferred site for drug absorption. Other medications that use the Acuform drug delivery technology include Gralise, Glumetza, Janumet XR, and Nucynta ER.

Is Xartemis XR considered a controlled substance?

Yes. Xartemis XR is a schedule II narcotic, meaning it has been determined to have high potential for abuse and addiction. Schedule II narcotic prescriptions, by law, are not allowed to have refills prescribed and in most instances must have a handwritten prescription from your doctor.

For more information on controlled substance prescriptions, see the DEA website here.

For more information on Xartemis XR, you can find the product website here.

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