Successful Dose Finding with Sublingual Fentanyl Tablet: Combined Results from 2 Open-Label Titration Studies

Pain Practice

Volumn 12, Issue 6, 2012, Pages 449-456

  Nalamachu, Srinivas R ^a   Rauck, Richard L ^b   Wallace, Mark S ^c   Hassman, David ^d   Howell, Julian ^e  

^a Clinical Research   (United States)

^b Center for Clinical Research   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d Comprehensive Clinical Research ^*  (United States)

^e KYOWA HAKKO KOGYO CO LTD   (Japan)

Author keywords

Analgesics; Cancer; Opioid

Indexed keywords

FENTANYL; HYDROCODONE; MORPHINE; OPIATE; OXYCODONE; PARACETAMOL;

ADULT; AGED; ANALGESIA; ARTICLE; BODY MASS; BREAKTHROUGH PAIN; CANCER PAIN; DIARRHEA; DIZZINESS; DOSE RESPONSE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; NAUSEA; PAIN ASSESSMENT; PHASE 2 CLINICAL TRIAL (TOPIC); SOMNOLENCE; TABLET; TABLET FORMULATION; VOMITING;

EID: 84863540906     PISSN: 15307085     EISSN: 15332500     Source Type: Journal    
DOI: 10.1111/j.1533-2500.2011.00525.x     Document Type: Article

References (28)

1. Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain. 1990;41:273-281.
2. Bennett D, Burton AW, Fishman S, et al. Consensus panel recommendations for the assessment and management of breakthrough pain. Part 1-assessment. PT. 2005;30:296-301.
3. Caraceni A, Martini C, Zecca E, et al. Breakthrough pain characteristics and syndromes in patients with cancer pain. An international survey. Palliat Med. 2004;18:177-183.
4. Svendsen KB, Andersen S, Arnasin S, et al. Breakthrough pain in malignant and non-malignant diseases: a review of prevalence, characteristics and mechanisms. Eur J Pain. 2005;9:195-206.
5. Portenoy RK, Payne D, Jacobsen P. Breakthrough pain: characteristics and impact in patients with cancer pain. Pain. 1999;81:129-134.
6. Osborne R, Joel S, Trew D, et al. Morphine and metabolite behavior after different routes of morphine administration: demonstration of the importance of the active metabolite morphine-6-glucuronide. Clin Pharmacol Ther. 1990;47:12-19.
7. Poyhia R, Seppala T, Olkkola KT, et al. The pharmacokinetics and metabolism of oxycodone after intramuscular and oral administration to healthy subjects. Br J Clin Pharmacol. 1992;33:617-621.
8. Leow KP, Smith MT, Watt JA, et al. Comparative oxycodone pharmacokinetics in humans after intravenous, oral, and rectal administration. Ther Drug Monit. 1992;14:479-484.
9. Leow KP, Smith MT, Watt JA, et al. Single-dose and steady-state pharmacokinetics and pharmacodynamics of oxycodone in patients with cancer. Clin Pharmacol Ther. 1992;52:487-495.
10. Zepetella G. Opioids for cancer breakthrough pain: a pilot study report of patient assessment of time to meaningful pain relief. J Pain Symptom Manage. 2008;35:563-567.
11. Zepetella G, Ribeiro MD. Opioids for the management of breakthrough (episodic) pain in cancer patients. Cochrane Database Syst Rev. 2006;Issue 1:CD004311.
12. Bennett D, Burton A, Fishman S, et al. Consensus panel recommendations for the assessment and management of breakthrough pain: Part II-management. PT. 2005;30:354-361.
13. Portenoy RK, Payne R, Coluzzi P, et al. Oral transmucosal fentanyl citrate (OTFC) for the treatment of breakthrough pain in cancer patients: a controlled dose titration study. Pain. 1999;79:303-312.
14. Cephalon, Inc. Actiq (Fentanyl Citrate) Oral Transmucosal Lozenge [Prescribing Information]. Frazer, PA: Cephalon, Inc.; 2009.
15. Farrar JT, Cldary J, Rauck R, Busch M, Nordbrock E. Oral transmucosal fentanyl citrate: randomized, double-blinded, placebo-controlled tiral for treatment of breakthrough pain in cancer patients. J Natl Cancer Inst. 1998;90:611-616.
16. Darwish M, Kirby M, Robertson P Jr, Tracewell W, Jiang JG. Absolute and relative bioavailability of fentanyl buccal tablet and oral transmucosal fentanyl citrate. J Clin Pharmacol. 2007;47:343-350.
17. Cephalon, Inc. Fentora (Fentanyl Buccal Tablet) [Prescribing Information]. Frazer, PA: Cephalon, Inc.; 2009.
18. Portenoy RK, Taylor D, Messina J, Tremmel L. A randomized, placebo-controlled study of fentanyl buccal tablet for breakthrough pain in opioid-treated patients with cancer. Clin J Pain. 2006;22:805-811.
19. Vasisht N, Gever LN, Tagarro I, Finn AL. Evaluation of the single- and multiple-dose pharmacokinetics of fentanyl buccal soluble film in normal healthy volunteers. J Clin Pharmacol. 2010;50:785-791.
20. Meda Pharmaceuticals Inc. Onsolis (Fentanyl Buccal Soluble Film) [Prescribing Information]. Somerset, NJ: Meda Pharmaceuticals Inc.; 2009.
21. Rauck R, North J, Gever LN, Tagarro I, Finn AL. Fentanyl buccal soluble film (FBSF) for breakthrough pain in patients with cancer: a randomized, double-blind, placebo-controlled study. Ann Oncol. 2010;21:1308-1314.
22. Bredenberg S, Duberg M, Lennernäs H, et al. In vitro and in vivo evaluation of a new sublingual tablet system for rapid oromucosal absorption using fentanyl citrate as the active substance. Eur J Pharm Sci. 2003;20:327-334.
23. ProStrakan Ltd. Abstral (Fentanyl) Sublingual Tablets CII [Prescribing Information]. Galashiels, U.K.; ProStrakan Ltd.; 2010.
24. Rauck RL, Tark M, Reyes E, et al. Efficacy and long-term tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain. Curr Med Res Opin. 2009;25:2877-2885.
25. Nalamachu S, Blair-Britt L, Cohen S, et al. Long-term effectiveness and tolerability of sublingual fentanyl citrate orally disintegrating tablet for the treatment of breakthrough cancer pain. Curr Med Res Opin. 2011;27:519-530.
26. Hagan NA, Fisher K, Victorino C, Farrar JT. A titration strategy is needed to manage breakthrough cancer pain effectively: observations from data pooled from three clinical trials. J Palliat Med. 2007;10:47-54.
27. Farrar JT, Cleary J, Rauck R, Busch M, Nordbrock E. Oral transmucosal fentanyl citrate: randomized, double-blinded, placebo-controlled trial for treatment of breakthrough pain in cancer patients. N Engl J Med. 1997;336:1465-1471.
28. Ward J, Laird B, Fallon M; BTcP Registry Group. The UK breakthrough cancer pain registry: origin, methods and preliminary data. Presented at The Compass Collaborative Annual Scientific Meeting, April 14 to 15, 2011; Edinburgh, U.K.