Dose proportionality of fentanyl buccal tablet in doses ranging from 600 to 1300μg in healthy adult subjects: A randomized, open-label, four-period, crossover, single-centre study

Clinical Drug Investigation

Volumn 30, Issue 6, 2010, Pages 365-373

  Darwish, Mona ^a   Kirby, Mary ^a   Robertson Jr , Philmore ^a   Tracewell, William ^a   Xie, Fang ^a  

^a CEPHALON INC   (United States)

Author keywords

Buccal; Cancer pain; Fentanyl; Opioid analgesics; Pharmacokinetics; Treatment

Indexed keywords

FENTANYL; FENTANYL CITRATE; NALTREXONE;

ABDOMINAL PAIN; ADULT; APPLICATION SITE REACTION; AREA UNDER THE CURVE; ARTICLE; BODY MASS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; CROSSOVER PROCEDURE; DIZZINESS; DRUG ELIMINATION; DRUG FATALITY; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HUMAN; HUMAN EXPERIMENT; LOW DRUG DOSE; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NORMAL HUMAN; PARESTHESIA; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SORE THROAT; TABLET FORMULATION; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADMINISTRATION, BUCCAL; ADOLESCENT; ADULT; ANALGESICS, OPIOID; AREA UNDER CURVE; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FENTANYL; HUMANS; MALE; MIDDLE AGED; NALTREXONE; NARCOTIC ANTAGONISTS; TIME FACTORS; YOUNG ADULT;

EID: 77952078392     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.2165/11533360-000000000-00000     Document Type: Article

References (18)

1. Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain 1990 Jun; 41 3:273-81
2. Svendsen KB, Andersen S, Arnason S, et al. Breakthrough pain in malignant and non-malignant diseases: a review of prevalence, characteristics and mechanisms. Eur J Pain 2005 Apr; 9 2:195-206
3. Durfee S, Messina J, Khankari R. Fentanyl effervescent buccal tablets: enhanced buccal absorption. Am J Drug Deliv 2006;4(1):1-5
4. Fentora [package insert]. Frazer (PA): Cephalon, Inc., 2009 Dec
5. Simpson DM, Messina J, Xie F, et al. Fentanyl buccal tablet for the relief of breakthrough pain in opioid-tolerant adult patients with chronic neuropathic pain: a multicenter, randomized, double-blind, placebo-controlled study. Clin Ther 2007 Apr; 29 4:588-601 (Pubitemid 47016640)
6. Portenoy RK, Messina J, Xie F, et al. Fentanyl buccal tablet (FBT) for relief of breakthrough pain in opioid-treated patients with chronic low back pain: a randomized, placebocontrolled study. Curr Med Res Opin 2007 Jan; 23 1:223-33 (Pubitemid 46191684)
7. Portenoy RK, Taylor D, Messina J, et al. A randomized, placebo-controlled study of fentanyl buccal tablet for breakthrough pain in opioid-treated patients with cancer. Clin J Pain 2006 Nov; 22 9:805-11 (Pubitemid 44627444)
8. Slatkin NE, Xie F, Messina J, et al. Fentanyl buccal tablet for relief of breakthrough pain in opioid-tolerant patients with cancer-related chronic pain. J Support Oncol 2007 Jul; 5 7:327-34
9. Darwish M, Kirby M, Robertson Jr P, et al. Pharmacokinetic properties of fentanyl effervescent buccal tablets: a phase I, open-label, crossover study of single-dose 100, 200, 400, and 800 μg in healthy adult volunteers. Clin Ther 2006 May; 28 5:707-14
10. Darwish M, Tempero K, Kirby M, et al. Pharmacokinetics and dose proportionality of fentanyl effervescent buccal tablets in healthy volunteers. Clin Pharmacokinet 2005;44(12):1279-86
11. Data on file, Cephalon, Inc., Frazer (PA), 2006
12. International Conference on Harmonisation Working Group. ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6 (R1). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; June 10, 1996; Washington, DC [online]. Available from URL: http://www.ich.org/LOB/media/MEDIA482pdf [Accessed 2009 Sep. 9]
13. Darwish M, Kirby M, Robertson Jr P, et al. Absolute and relative bioavailability of fentanyl buccal tablet and oral transmucosal fentanyl citrate. J Clin Pharmacol 2007 Mar; 47 3:343-50
14. Smith BP, Vandenhende FR, DeSante KA, et al. Confidence interval criteria for assessment of dose proportionality. Pharm Res 2000 Oct; 17 10:1278-83
15. Ptachcinski RJ, Venkataramanan R, Burckart GJ. Clinical pharmacokinetics of cyclosporin. Clin Pharmacokinet 1986 Mar; 11 2:107-32
16. Bower S. The uptake of fentanyl by erythrocytes. J Pharm Pharmacol 1982 Mar; 34 3:181-5
17. Darwish M, Tempero K, Kirby M, et al. Relative bioavailability of the fentanyl effervescent buccal tablet (FEBT) 1080 μg versus oral transmucosal fentanyl citrate 1600 μg and dose proportionality of FEBT 270-1300 μg: a single-dose, randomized, open-label, threeperiod study in healthy adult volunteers. Clin Ther 2006 May; 28 5:715-24
18. Weinstein SM, Messina J, Xie F. Fentanyl buccal tablet for the treatment of breakthrough pain in opioid-tolerant patients with chronic cancer pain: a long-term, open-label safety study. Cancer 2009 Apr. 16;11:2571-9