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Home » Drug Information » FDA Approved Drugs » 2014
Medical Areas: Neurology | Family Medicine

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Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Mallinckrodt Pharmaceuticals
Approval Status: Approved March 2014
Treatment Area: management of acute pain

General Information

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Xartemis XR is specifically indicated for the management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate.

Xartemis XR is supplied as a tablet for oral administration. The recommended dose is 2 tablets every 12 hours administered with or without food. The second dose of 2 tablets may be administered as early as 8 hours after the initial dose if patients require analgesia at that time. Subsequent doses are to be administered 2 tablets every 12 hours. The tablets should be swallowed whole, one at a time, with enough water to ensure complete swallowing immediately after placing in mouth. Do not break, chew, crush, cut, dissolve or split the tablets. Breaking, chewing, crushing, cutting, dissolving or splitting Xartemis XR tablets will result in uncontrolled delivery of oxycodone and can lead to overdose or death.

Clinical Results

FDA Approval
The FDA approval of Xartemis XR was based on a randomized, double blind, placebo controlled, parallel arm multi dose study comparing Xartemis XR and placebo in 303 subjects with acute pain following a unilateral first metatarsal bunionectomy. All subjects met the criteria of pain intensity >4 on a 0 to 10 numerical pain rating scale and received a fixed-dose of 2 tablets of Xartemis XR (7.5 mg oxycodone hydrochloride and 325 mg acetaminophen) tablets or placebo every 12 hours over 48 hours. Ibuprofen 400 mg every 4 hours as needed was allowed as rescue medication. Mean baseline pain intensity scores were 6.2 in the Xartemis XR group and 6.0 in the placebo group. Approximately 85% of the 150 subjects treated with Xartemis XR and 98% of the 153 subjects treated with placebo took rescue medication at least once for pain management during the 48 hours after the first dose. Rescue medication was used by less than 50% of the Xartemis XR-treated patients after the first dose interval. Pain intensity was recorded at 2, 4, 8, and 12 hours after each dose, with additional recordings at 15, 30, 45, 60, and 90 minutes after the first dose. The median time to onset of pain relief was less than one hour for Xartemis XR. The primary endpoint was the summed pain intensity difference (change in pain from baseline) over 48 hours (SPID48), which demonstrated improvement in pain from baseline for the Xartemis XR treatment group compared to placebo.

Side Effects

Adverse events associated with the use of Xartemis XR may include, but are not limited to, the following:

  • nausea
  • dizziness
  • headache
  • vomiting
  • constipation
  • somnolence

Mechanism of Action

Xartemis is an extended release formulation of oxycodone hydrochloride and acetaminophen. Oxycodone HCl is an opioid agonist and is relatively selective for the mu receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all opioid agonists, there is no ceiling effect to analgesia. Acetaminophen is a non-opioid, non-salicylate analgesic, and antipyretic. The site and mechanism for the analgesic effect of acetaminophen has not been determined. The antipyretic effect of acetaminophen is accomplished through the inhibition of endogenous pyrogen action on the hypothalamic heat-regulating centers.

Additional Information

For additional information regarding Xartemis XR or acute pain, please visit the Xartemisxr web page.