FDA approves Tapentadol Immedate Release for moderate to severe pain
November 22, 2008 by Marijke Durning, RN
Filed under Diseases & Conditions
Press Release
FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain
Millions of Americans with moderate to severe acute pain and their health-care providers will soon have a new treatment option. The U.S. Food and Drug Administration (FDA) has approved tapentadol immediate-release tablets for the relief of moderate to severe acute pain in adults 18 years of age or older.
Tapentadol is a new centrally acting oral analgesic. It has two mechanisms of action, combining mu-opioid receptor agonism and norepinephrine reuptake inhibition.
Tapentadol tablets have been approved in 50 mg, 75 mg and 100 mg doses.
The approval was based on data from clinical studies involving more than 2,100 patients. The studies, which were presented at the 27th Annual Scientific Meeting of the American Pain Society earlier this year, showed that tapentadol provided significant relief of moderate to severe acute pain compared to placebo.
Following yesterday’s FDA approval, and as per Federal regulation for all controlled substances, tapentadol will be reviewed by the U.S. Drug Enforcement Agency for scheduling, and it cannot be sold until it receives a scheduling classification.
A trade name for tapentadol has not yet been determined.
SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Image: Newscom
Tags: FDA drug approval, tapentadol, chronic pain blog, pain blog, acute pain, moderate to severe pain
I wonder if this would be contraindicated for people already taking antidepressants with those inhibitors in them. Sounds like a very promising drug. I’ll have to ask my doctor about it – always looking for something other than the Vicodin. I hate the thought of what that is doing to my liver…
Interesting. I have never heard of this previously.