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The FDA has approved tapentadol hydrochloride (Nucynta – Ortho-McNeil Janssen) for oral treatment of moderate to severe acute pain in patients ≥18 years old. It has been classified as a Schedule II controlled substance.
PHARMACOLOGY — Tapentadol is a centrally-acting synthetic oral analgesic; it is, like morphine, a mu-opioid receptor agonist and, like tricyclic antidepressants, a norepinephrine reuptake inhibitor. It has some structural similarity to tramadol (Ultram, and others), which is also an opioid receptor agonist and an inhibitor of norepinephrine (and serotonin) reuptake, but is not classified as a controlled substance by the FDA.1
CLINICAL STUDIES — In a randomized, double-blind trial in 400 patients with moderate to severe postoperative dental pain, total pain relief scores over 8 hours with single doses of tapentadol... more