Tapentadol: An initial analysis—follow-up

Authors

  • Tanya Nelson, PharmD
  • Vincent Brett, MS, RPh
  • Eric Prommer, MD

Keywords:

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Abstract

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Author Biographies

Tanya Nelson, PharmD

Manager, Medical Information and Services Ortho-McNeil Janssen Scientific Affairs, LLC

Vincent Brett, MS, RPh

Associate Director, Medical Information and Services Ortho-McNeil Janssen Scientific Affairs, LLC

Eric Prommer, MD

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References

Tzschentke TM, Christoph T, Kogel B, et al.: ( - ) - (1R,2R) - 3 - (3-Dimethylamino-1-ethyl-2-methyl-propyl)-phenol hydro - chloride (tapentadol HCl): A novel m opioid receptor agonist/norepinephrine reuptake inhibitor with broad spectrum analgesic properties. J Pharmacol Exp Ther. 2007; 323(1): 265-276.

NUCYNTA® (tapentadol) [prescribing information]. Raritan, NJ: Ortho-McNeil-Janssen Pharmaceuticals, Inc. Rev November 2010.

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Tzschentke TM, Jahnel U, Kogel B, et al.: Tapentadol hydrochloride: A next generation, centrally acting analgesic with two mechanisms of action in a single molecule. Drugs Today. 2009; 45: 483-496.

Smit JW, Oh C, Rengelshausen J, et al.: Effects of acetaminophen, naproxen, and acetylsalicylic acid on tapentadol pharmacokinetics: Results of two randomized, open-label, crossover, drug-drug interaction studies. Pharmacotherapy. 2010; 30: 25-34.

Terlinden R, Ossig J, Fliegert F, et al.: Absorption, metabolism, and excretion of 14C-labeled Tapentadol HCl in healthy male subjects. Eur J Drug Metab Pharmacokinet. 2007; 32(3): 163-169.

Terlinden R, Kogel BY, Engleberger W, et al.: In vitro and in vivo characterization of tapentadol metabolites. Methods Find Exp Clin Pharmacol. 2010; 32(1): 31-38.

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Smit H, Kleideiter E, Brett M, et al.: Pharmacokinetics of tapentadol in subjects with varying degrees of renal impairment. J Clin Pharmacol. 2010; 50: 1079.

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Xu XS, Smit JW, Lin R: Population pharmacokinetics of tapentadol immediate-release (IR) in healthy subjects and patients with moderate or severe pain. Clin Pharmacokinet. 2010; 49(10): 671-682.

Daniels SE, Upmalis D, Okamoto A, et al.: A randomized, double-blind, phase III study comparing multiple doses of tapentadol IR, oxycodone IR, and placebo for postoperative (bunionectomy) pain. Curr Med Res Opin. 2009; 25: 765-776.

Daniels S, Casson E, Stegmann J-U, et al.: A randomized, double-blind, placebo-controlled phase 3 study of the relative efficacy and tolerability of tapentadol IR and oxycodone IR for acute pain. Curr Med Res Opin. 2009; 25: 1551-1561.

Hartrick C, Van Hove I, Stegmann J-U, et al.: 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. Clin Ther. 2009; 31: 260-271.

Hale M, Upmalis D, Okamoto A, et al.: Tolerability of tapentadol immediate release in patients with lower back pain or osteoarthritis of the hip or knee over 90 days: A randomized, double-blind study. Curr Med Res Opin. 2009; 25: 1095-1104.

Kleinert R, Lange C, Steup A, et al.: Single dose analgesic efficacy of tapentadol in postsurgical dental pain: Results of a randomized, double-blind, placebo-controlled study. Anesth Analg. 2008; 107(6): 2048-2055.

Etropolski M, Shapiro D, Okamoto A, et al.: Efficacy and safety of tapentadol extended release (ER) for diabetic peripheral neuropathic pain: Results of a randomized-withdrawal, double-blind, placebo-controlled phase III study. Poster presented at the 61st Annual Meeting of the American Academy of Neurology (AAN); April 25-May 2, 2009; Seattle, Washington, USA. Neurology. 2009; 72(Suppl): Abstract P05.047.

Buynak R, Shapiro DY, Okamoto A, et al.: Efficacy and safety of tapentadol extended release for the management of chronic low back pain: Results of a prospective, randomized, doubleblind, placebo-, and active-controlled Phase III study. Exp Opin Pharmacother. 2010; 11(11): 1787-1804.

Afilalo M, Etropolski M, Kuperwasser B, et al.: Efficacy and safety of tapentadol extended release compared with oxycodone controlled release for the management of moderate to severe chronic pain related to osteoarthritis of the knee: A randomized, double-blind, placebo-, and active-controlled Phase III study. Clin Drug Investig. 2010; 30(8): 489-505.

Etropolski M, Okamoto A, Shapiro DY, et al. Dose conversion between tapentadol immediate release and extended release for low back pain. Pain Physician. 2010; 13: 61-70.

Gomes I, Gupta A, Filipovska J, et al.: A role for heterodimerization of and opiate receptors in enhancing morphine analgesia. Proceedings of the National Academy of Sciences of the United States of America 2004; 101(14): 5135.

Tzschentke TM, Christoph T, Kogel B, et al.: (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol hydrochloride (tapentadol HCl): a novel mu-opioid receptor agonist/norepinephrine reuptake inhibitor with broad-spectrum analgesic properties. J Pharmacol Exp Ther. 2007; 323(1): 265-276.

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Published

01/15/2018

How to Cite

Nelson, PharmD, T., V. Brett, MS, RPh, and E. Prommer, MD. “Tapentadol: An Initial analysis—follow-up”. Journal of Opioid Management, vol. 7, no. 2, Jan. 2018, pp. 87-92, https://wmpllc.org/ojs/index.php/jom/article/view/864.

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Section

Letters to the Editor