Unique pharmacology of tapentadol for treating acute and chronic pain

Bibliography

• Krüger-Hellwig A. “Grünenthal GmbH Presents Tapentadol, a Novel Centrally Acting Analgesic, at the 25th Annual Scientific Meeting of The American Pain Society”. PR Newswire. Retrieved 2007
   Google Scholar
• Proposed Rule - Schedules of Controlled Substances: Placement of Tapentadol Into Schedule II February 17, 2009
   Google Scholar
• Institute of Medicine Report from the Committee on Advancing Pain Research, Care, and Education: Relieving Pain in America, A Blueprint for Transforming Prevention, Care, Education and Research. The National Academies Press, 2011. Available from: http://books.nap.edu/openbook.php?record_id=13172&page=1
   Google Scholar
• Tapentadol Pre-Review Report. Expert Committee on Drug Dependence Thirty-fifth Meeting; 4-8 June 2012; Hammamet, Tunisia
   Google Scholar
• Ravikumar K, Sridhar B, Pradhan N, et al. Four stereoisomerof the novel μ-opioid receptor agonist tapentadol hydrochloride. Acta Crystallogr C 2011;67(Pt 2):o71-6
   PubMed Web of Science ®Google Scholar
• NUCYNTA® (tapentadol) immediate-release oral tablets C-II 2013. Available from: http://www.nucynta.com/_assets/pdf/nucynta-pi.pdf [Last Accessed 5 June 2015]
   Google Scholar
• NUCYNTA® ER (tapentadol) extended-release oral tablets C-II 2014. Available from: http://www.nucynta.com/_assets/pdf/nucyntaer-pi.pdf [Last Accessed 5 June 2015]
   Google Scholar
• Schröder W, Tzschentke T.M, Terlinden R, et al. Synergistic Interaction between the Two Mechanisms of Action of Tapentadol in Analgesia. J Pharmacol Exp Ther 2011;337:312-20
   PubMed Web of Science ®Google Scholar
• Kress HG. Tapentadol and its two mechanisms of action: is there a new pharmacological class of centrally-acting analgesics on the horizon? Eur J Pain 2010;14(8):781-3
   PubMed Web of Science ®Google Scholar
• Wigdor S, Wilcox GL. Central and systemic morphine-induced antinociception in mice: contribution of descending serotoninergic and noradrenergic pathways. J Pharmacol Exp Ther 1987;242:90-5
   PubMed Web of Science ®Google Scholar
• Tzschentke TM, De Vry J, Terlinden R, et al. Tapentadol hydrochloride. Drugs Future 2006;31:1053-61
   Web of Science ®Google Scholar
• Tzschentke TM, Christoph T, Kögel 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):265-76
   PubMed Web of Science ®Google Scholar
• Tzschentke TM. NA and 5-HT reuptake inhibitors and α2-agonists. In: Buschmann H, Christoph T, Maul C, Sundermann B, Editors. Analgesics: from chemistry and pharmacology to clinical application. Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, Germany. 2002. p. 265-84
   Google Scholar
• Tzschentke TM, jannel U, Kogel B, et al. Tapentadol hydrochloride: a next-generation, centrally acting analgesic with two mechanisms of action in a single molecule. Drugs Today (Barc) 2009;45:483-96
   PubMed Web of Science ®Google Scholar
• Schröder W, Vry JD, Tzschentke TM, et al. Differential contribution of opioid and noradrenergic mechanisms of tapentadol in rat models of nociceptive and neuropathic pain. Eur J Pain 2010;14:814-21
   PubMed Web of Science ®Google Scholar
• Christoph T, De Vry J, Tzschentke TM. Tapentadol, but not morphine, selectively inhibits disease- related thermal hyperalgesia in a mouse model of diabetic neuropathic pain. Neurosci Lett 2010;470:91-4
   PubMed Web of Science ®Google Scholar
• Fishbain D. Evidence-based data on pain relief with antidepressants. Ann Med 2000;32:305-16
   PubMed Web of Science ®Google Scholar
• Vadivelu N, Timchenko A, Huang Y, et al. Tapentadol extended- release for treatment of chronic pain: a review. J Pain Res 2011;4:211-18
   PubMedGoogle Scholar
• Wade WE, Spruill WJ. Tapentadol hydrochloride: a centrally acting oral analgesic. Clin Ther 2009;31(12):2804-18
   PubMed Web of Science ®Google Scholar
• Hartrick CT, Rodriquez Hernandez JR. Tapentadol for pain: a treatment evaluation. Expert Opin Pharmacother 2012;13:283-6
   PubMed Web of Science ®Google Scholar
• Max MB, Lynch SA, Muir J, et al. Effects of desipramine, amitriptyline, and fluoxetine on pain in diabetic neuropathy. N Engl J Med 1992;326:1250-6
   PubMed Web of Science ®Google Scholar
• Suzuki T, Ueta K, Tamagaki S. Antiallodynic and antihyperalgesic effect of milnacipran in mice with spinal nerve ligation. Anesth Analg 2008;106:1309-15
   PubMed Web of Science ®Google Scholar
• Pasero C. Tapentadol for multimodal pain management. J Perianesth Nurs 2011;26:343-6
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration. The Biopharmaceutics Classification System (BCS) Guidance 2009. Available from: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm128219.htm [Last accessed 11 March 2015]
   Google Scholar
• Terlinder R, Ossig J, Fliegert F, et al. Absorbtion, metabolism, and excretion pf 14C-labeled tapentadol HCl in healthy male subjects. Eur J Drug Metab Pharmacokinet 2007;32(3):163-9
   PubMed Web of Science ®Google Scholar
• Göhler K, Brett M, Smit JW, et al. Comparative pharmacokinetics and bioavailability of tapentadol following oral administration of immediate- and prolonged-release formulations. Int J Clin Pharm Th 2013;51(4):338-48
   PubMed Web of Science ®Google Scholar
• Kneip C, Terlinden R, Beier H, Chen G. Investigations into the drug-drug interaction potential of tapentadol in human liver microsomes and fresh human hepatocytes. Drug Metab Lett 2008;2(1):65-75
   Google Scholar
• Australian Public Assessment Report for Tapentadol. AusPAR Palexia SR Tapentadol CSL Ltd PM-2009-02489-3-1 Final 28 February 2011
   Google Scholar
• Clinical Pharmacology and Biopharmaceutics Review(s). Center for Drug Evaluation and Research Application Number 22-304
   Google Scholar
• Xu SX, Smit JW, Lin R, et al. Population pharmacokinetics of tapentadol immediate release in healthy subjects and patients with moderate or severe pain. Clin Pharmacokinet 2010;49(10):671-82
   PubMed Web of Science ®Google Scholar
• Mathijssen RH, Sparreboom A. Influence of lean body weight on anticancer drug clearance. Clin Pharmacol Ther 2009;85(1):23
   PubMed Web of Science ®Google Scholar
• Giorgi M, Meizler A, Mills PC. Pharmacokinetics of the novel atypical opioid tapentadol following oral and intravenous administration in dogs. Vet J 2012;194:309-13
   PubMed Web of Science ®Google Scholar
• Giorgi M, Mills PC, Tayari H, et al. Plasma concentrations of tapentadol and clinical evaluations of a combination of tapentadol plus sevoflurane for surgical anaesthesia and analgesia in rabbits (Oryctolagus cuniculus) undergoing orchiectomy. Israel Journal of Veterinary Medicine 2013;68:141-8
   Web of Science ®Google Scholar
• Stegmann JU, Weber H, Steup A, et al. The efficacy and tolerability of multiple-dose tapentadol immediate release for the relief of cute pain following orthopedic (bunionectomy) surgery. Curr Med Res Opin 2008;24(11):3185-96
   PubMed Web of Science ®Google Scholar
• Lee YK, Ko JS, Rhim HY, et al. Acute postoperative pain relief with immediate-release tapentadol: randomized, double-blind, placebo-controlled study conducted in South Korea. Curr Med Res Opin 2014;30(12):2561-70
   PubMed Web of Science ®Google Scholar
• Daniels S, Casson E, Stegmann JU, 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;25:1551-61
   PubMed Web of Science ®Google Scholar
• 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;25:765-76
   PubMed Web of Science ®Google Scholar
• Biondi D, Xiang J, Benson C, et al. Tapentadol immediate release versus oxycodone immediate release for treatment of acute low back pain. Pain Physician 2013;16:E237-46
   PubMed Web of Science ®Google Scholar
• Kleinert R, Lange C, Steup A, et al. Single dose analgesic efficacy of tapentadol in postsurgical dental pain: The results of a randomized, double-blind, placebo-controlled study. Anesth Analg 2008;107(6):2048-55
   PubMed Web of Science ®Google Scholar
• Hartrick C, Van Hove I, Stegmann JU, 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(2):260-71
   PubMed Web of Science ®Google Scholar
• Christoph T, De Vry J, Schiene K, et al. Synergistic antihypersensitive effects of pregabalin and tapentadol in a rat model of neuropathic pain. Eur J Pharmacol 2011;666(1-3):72-9
   PubMed Web of Science ®Google Scholar
• 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, double-blind, placebo- and active-controlled Phase III study. Expert Opin Pharmachother 2010;11(11):1787-804
   PubMed Web of Science ®Google Scholar
• Schwartz S, Etropolski M, Shapiro DY, et al. Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized-withdrawal, placebo-controlled trial. Curr Med Res Opin 2011;27:151-62
   PubMed Web of Science ®Google Scholar
• Vinik A, Shapiro DY, Rauschkolb C, et al. Efficacy and tolerability of tapentadol extended release in patients with chronic, painful diabetic peripheral neuropathy: results of a phase 3, randomized-withdrawal, placebo-controlled study. J Pain 2012;13:S72
   Google Scholar
• Afilalo M, Etropolski MS, 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;30:489-505
   PubMed Web of Science ®Google Scholar
• Kress HG, Koch ED, Kosturski H, et al. Tapentadol prolonged release for managing moderate to severe, chronic malignant tumor-related pain. Pain Physician 2014;17:329-43
   PubMed Web of Science ®Google Scholar
• Wild JE, Grond S, Kuperwasser B, et al. Long-term safety and tolerability of tapentadol extended release for the management of chronic low back pain or ostheoarthritis pain. Pain Pract 2010;10:416-27
   PubMed Web of Science ®Google Scholar
• Smith JW, Oh C, Rengelshausen J, et al. The effect 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
   PubMed Web of Science ®Google Scholar
• Steigerwald I, Muller M, Davies A, et al. Effectiveness and safety of tapentadol prolonged release for severe, chronic low back pain with or without a neuropathic pain component: results of an open-label, phase 3b study. Curr Med Res Opin 2012;28:911-36
   PubMed Web of Science ®Google Scholar
• Steigerwald I, Muller M, Kujawa J, et al. Effectiveness and safety of tapentadol prolonged release on-demand for the management of severe, chronic osteoarthritis-related knee pain: results of an open-label, phase 3b study. J Pain Res 2012;5:121-38
   PubMedGoogle Scholar
• Gálvez R. ShäferM, Hans G, et al. Tapentadol prolonged release versus strong opioids for severe, chronic low back pain: results of an open-label, phase IIIb study. Adv Ther 2013;30:229-59
   PubMed Web of Science ®Google Scholar
• Steigerwald I, Schenk M, Lahne U, et al. Effectiveness and tolerability of tapentadol prolonged release compared with prior opioid therapy for the management of severe, chronic osteoarthritis pain. Clin Drug Investig 2013;33:607-19
   PubMed Web of Science ®Google Scholar
• Ashworth J, Kuperwasser B, Etropolski M, et al. Assessment of opioid withdrawal in patients treated with tapentadol prolonged release during an open-label extension study. Poster presented at the Osteoarthritis Research Society International (OARSI) 2010 World Congress On Osteoarthritis; 23-26 September 2010; Brussels, Belgium
   Google Scholar
• Lange R, Kuperwasser B, Etropolski M, et al. Treatment discontinuations from an open-label extension study of tapentadol prolonged release (PR) in patients with moderate to severe chronic pain. Ann Rheum Dis 2010;69:288
   Google Scholar
• Etropolski M, Van Hove I, Ashworth J, et al. Efficacy and tolerability of tapentadol extended release (ER) in patients with moderate to severe osteoarthritis or low back pain over 2 years of treatment [Abstract P-9115]. Presented at the 64th Annual Postgraduate Assembly in Anesthesiology (PGA); 10-14 December 2010. New York, NY
   Google Scholar
• Product monograph. NNucynta® IR Tapentadol. Immediate-Release Tablets 50mg, 75 mg, 100mg.Tapentadol (as tapentadol hydrochloride). Opioid Analgesic. Janssen Inc, Toronto, Ontario, Canada 2014
   Google Scholar
• Tapentadol. Critical Review Report. Expert Committee on Drug Dependence. Thirty-sixth Meeting; 16-20 June 2014; Geneva
   Google Scholar
• Gallego AO, Barón MG, Arranz EE. Oxycodone: a pharmacological and clinical review. Clin Transl Oncol 2007;9:298-307
   PubMed Web of Science ®Google Scholar
• Grond S, Sablotzki A. Clinical pharmacology of tramadol. Clin Pharmacokinet 2004;43:879-923
   PubMed Web of Science ®Google Scholar
• Currently ongoing studies on tapentadol. Available from: https://clinicaltrials.gov/ct2/results?term=tapentadol&Search=Search [Last accessed 28 June 2015]
   Google Scholar