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Home | Clinical Trials

FDA Approved Drugs » 2008
Medical Areas: Neurology

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Nucynta (tapentadol)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Ortho-McNeil Pharmaceutical
Approval Status: Approved November 2008
Treatment Area: acute pain

General Information

Nucynta is a centrally-acting synthetic analgesic. Although its exact mechanism is unknown, analgesic efficacy is thought to be due to mu-opioid agonist activity and the inhibition of norepinephrine reuptake.

Nucynta is specifically indicated for the relief of moderate to severe acute pain in patients 18 years of age or older.

Nucynta is supplied as an immediate release tablet for oral administration. The recommended initial dose of the drug is 50 mg, 75 mg, or 100 mg every 4 to 6 hours depending upon pain intensity.

Clinical Results

FDA Approval
The FDA approval of Nucynta was based on two randomized, double-blind, placebo- and active-controlled studies of moderate to severe pain from first metatarsal bunionectomy and end-stage degenerative joint disease.
Orthopedic Surgery: Bunionectomy
This randomized, double-blind, parallel-group, active- and placebo-controlled, multiple-dose study demonstrated the efficacy of 50 mg, 75 mg, and 100 mg Nucynta given every 4 to 6 hours for 72 hours. Efficacy was evaluated by comparing the sum of pain intensity difference over the first 48 hours (SPID48) versus placebo. Nucynta at each dose provided a greater reduction in pain compared to placebo based on SPID48 values. The proportions of patients who showed reduction in pain intensity at 48 hours of 30% or greater, or 50% or greater were significantly higher in patients treated with Nucynta at each dose versus placebo.
End-Stage Degenerative Joint Disease
This randomized, double-blind, parallel-group, active- and placebo-controlled, multiple-dose study evaluated the efficacy and safety of 50 mg and 75 mg Nucynta given every 4 to 6 hours during waking hours for 10 days in adults experiencing moderate to severe pain from end stage degenerative joint disease of the hip or knee. Nucynta 50 mg and 75 mg provided improvement in pain compared with placebo based on the 5-Day SPID. The proportions of patients who showed reduction in pain intensity at 5 days of 30% or greater, or 50% or greater were significantly higher in patients treated with Nucynta at each dose versus placebo.

Side Effects

Adverse events associated with the use of Nucynta may include, but are not limited to, the following:

  • nausea
  • dizziness
  • vomiting
  • somnolenceconstipation

Mechanism of Action

Nucynta is a centrally-acting synthetic analgesic. Although its exact mechanism is unknown, analgesic efficacy is thought to be due to mu-opioid agonist activity and the inhibition of norepinephrine reuptake.

Literature References

Hartrick C, Van Hove I, Stegmann JU, Oh C, Upmalis D Efficacy and tolerability of tapentadol immediate release and oxycodone HCl immediate release in patients awaiting primary joint replacement surgery for end-stage joint disease: a 10-day, phase III, randomized, double-blind, active- and placebo-controlled study. Clinical Therapeutics 2009 Feb;31(2):260-71

Daniels SE, Upmalis D, Okamoto A, Lange C, Häeussler J A randomized, double-blind, phase III study comparing multiple doses of tapentadol IR, oxycodone IR, and placebo for postoperative (bunionectomy) pain. Current medical research and opinion 2009 Mar;25(3):765-76

Stegmann JU, Weber H, Steup A, Okamoto A, Upmalis D, Daniels S The efficacy and tolerability of multiple-dose tapentadol immediate release for the relief of acute pain following orthopedic (bunionectomy) surgery. Current medical research and opinion 2008 Nov;24(11):3185-96

Additional Information

For additional information regarding Nucynta or acute pain, please visit the Nucynta web page.


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