The 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 centrally acting oral analgesic that combines mu-opioid receptor agonism and norepinephrine reuptake inhibition. The FDA approved tapentadol tablets 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 FDA approval, 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.
Click here for a full press release on the approval.