Tag: long acting opioids

FDA Approves Long-Lasting Narcotic – Oxycodone / Acetaminophen

March 19, 2014

The first FDA approved long-acting combination of narcotic analgesic oxycodone with acetaminophen is now available for pain management. It will be manufactured by Mallinckrodt and is a single strength tablet to be dosed twice daily. This new form of pain medicine is sold under the name Xartemis XR, and will treat patients with severe pain who don’t respond to alternate therapies.   Xartemis XR should not be used with other medicines that contain acetaminophen, nor should it be used in place of other oxycodone/acetaminophen products. Mallinckrodt is looking to provide more abuse-deterrent features for the FDA, as Xartemis does not currently have them.

“The FDA approval of Xartemis XR exemplifies Mallinckrodt’s dedication to developing and providing new treatment options for people with pain,” said Mark Trudeau, President and Chief Executive Officer of Mallinckrodt. “Mallinckrodt remains committed to continuing its work to develop innovative formulations for our product lines to help ensure access to appropriate pain treatment for the millions of patients suffering from acute pain, and we will continue to work closely with the FDA as we engage in further development programs for Xartemis XR and other products utilizing this technology platform.”

Warnings and Precautions
For those who manage workers’ compensation claims, the following warnings and precautions should be reviewed with claimants and their treating physicians before approval of this long acting opioid medication.
  • XARTEMIS XR contains oxycodone, a Schedule II controlled substance. As an opioid, XARTEMIS XR exposes users to the risks of addiction, abuse, and misuse. Abuse or misuse of XARTEMIS XR by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the oxycodone and can result in overdose and death. With intravenous abuse, the inactive ingredients in XARTEMIS XR can result in death, local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.
  • Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of XARTEMIS XR, the risk is greatest during the initiation of therapy or following a dose increase. Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients. In patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression, XARTEMIS XR may decrease respiratory drive to the point of apnea.
  • Hypotension, profound sedation, coma, respiratory depression, and death may result if XARTEMIS XR is used concomitantly with alcohol or other central nervous system (CNS) depressants.
  • Oxycodone may cause severe hypotension particularly in individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs which compromise vasomotor tone such as phenothiazines.
  • Due to the potential for acetaminophen hepatotoxicity at doses higher than 4000 milligrams/day, XARTEMIS XR should not be used concomitantly with other acetaminophen-containing products.

Impact on Settlement and MSA Projections

As a long acting opioid, XARTEMIS XR represents yet another medication to be added to the list of potentially addictive drugs approved by the FDA in 2014 (Zohydro, a new formulation of pure hydrocodone is scheduled for release in late March, 2014).  When the US represents only 5% of the world’s population, yet consumes more than 75% of the world’s prescription drugs, one should question the need for another opioid drug; especially when this formulation of oxycodone / acetaminophen is not available in a tamper proof formulation.  With overdose deaths involving opioid analgesics increasing from 4,030 deaths in 1999 to 16,651 in 2010, how can the benefits of this drug possibly outweigh the danger?

As a trigger for potential intervention, use of XARTEMIS XR to treat chronic pain for periods of more than 30 days, will be escalated to our medical team for review.  With availability as a single source drug only, XARTEMIS XR is extremely expensive.  If included in the drug regimen for an MSA beneficiary at the time of settlement, this would result in a high dollar.  When identified in the treatment regimen of an injured worker during the pre-MSA review our medical team with will dialogue with the treating physician in an effort to discontinue or replace XARTEMIS XR with a therapeutic equivalent medication to mitigate exposure with the MSA and achieve an optimal settlement.