What year was Nucynta (tapentadol) approved by the FDA?

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Nucynta FDA Approval Year

Nucynta (tapentadol) was approved by the FDA in November 2008 for the treatment of moderate-to-severe acute pain in adults. 1, 2

Initial Approval Details

  • The immediate-release formulation of tapentadol was the first new centrally acting analgesic approved by the FDA in 2008, representing a novel class of analgesics with dual mechanism of action 2

  • The drug was classified as a Schedule II controlled substance (C-II) at the time of its initial approval 1

Subsequent Formulation Approvals

  • Extended-release tapentadol (Nucynta ER) was subsequently approved in August 2011 for chronic pain management requiring continuous, around-the-clock opioid treatment 3, 4

  • The extended-release formulation was later approved for treatment of chronic painful diabetic neuropathy 5

Available Formulations

  • Immediate-release tablets are available in 50 mg, 75 mg, and 100 mg strengths for acute pain management 1, 5

  • Extended-release tablets are available in 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg strengths for chronic pain conditions 5

References

2
Research

Unique pharmacology of tapentadol for treating acute and chronic pain.

Expert opinion on drug metabolism & toxicology, 2015

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