New Opioid Not Recommended for Approval by FDA Panel
On April 22nd, 2014, a Food and Drug Administration advisory committee unanimously voted against recommending approval for the new opioid drug combination known as Moxduo. The FDA doesn’t have to follow these panel recommendations, but usually does.
Moxduo is a combination of two opioid painkillers, morphine and oxycodone, and was developed by QRxPharma. The company had argued that Moxduo could help alleviate moderate to severe pain with a lower risk of adverse effects than either drug taken alone.
Opioid medications are under particular scrutiny due to their widespread use and their preponderance for adverse effects. Patients taking opioids can sometimes develop side effects such as nausea, dizziness, and severe, sometimes fatal respiratory depression. Genetic variations to drug-processing enzymes, such as CYP2D6, can increase these risks.
Leading clinics are taking precautions to prevent these events. For example, St. Jude Children’s Research Hospital’s electronic health records (EHR) system reminds physicians to order CYP2D6 genotyping before prescribing codeine, another opioid, to children. QRxPharma argued that their new medication could help alleviate some of this burden.
However, the FDA panel disagreed with QRxPharma, saying there wasn’t sufficient evidence that Moxduo had fewer side effects. The FDA panel also argued that the combination drug may be easier to abuse. Many opioid drugs have extra compounds in them that discourage abuse by making them harder to take in nonstandard ways such as snorting or injecting. Moxduo did not contain these compounds.
To learn more about pharmacogenetics and pain management, go to http://genelex.com/clinical-guidance/pain/.
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