Fentanyl buccal soluble film (FBSF) for breakthrough pain in patients with cancer: A randomized, double-blind, placebo-controlled study

Annals of Oncology

Volumn 21, Issue 6, 2009, Pages 1308-1314

  Rauck, R ^a   North, J ^a   Gever, L N ^b   Tagarro, I ^c   Finn, A L ^d  

^a Carolinas Pain Institute   (United States)

^b Meda Pharmaceuticals Inc   (United States)

^c Meda Pharmaceuticals   (Spain)

^d BioDelivery Sciences International Inc   (United States)

Author keywords

Breakthrough cancer pain; Clinical study; Fentanyl buccal soluble film

Indexed keywords

BREAKYL; BUQUEL; FENTANYL; FENTANYL BUCCAL SOLUBLE FILM; HYDROCODONE; MORPHINE; NARCOTIC ANALGESIC AGENT; ONSOLIS; PLACEBO; UNCLASSIFIED DRUG; DRUG DOSAGE FORM;

ADULT; ARTICLE; CANCER PAIN; CENTRAL NERVOUS SYSTEM DISEASE; CHRONIC PAIN; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EDEMA; FEMALE; GASTROINTESTINAL DISEASE; HUMAN; MAJOR CLINICAL STUDY; MALE; MOUTH ULCER; MULTICENTER STUDY; NAUSEA AND VOMITING; PAIN; PAIN ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SOMNOLENCE; AGED; BUCCAL DRUG ADMINISTRATION; COMPLICATION; DOSE RESPONSE; DRUG DOSAGE FORM; MIDDLE AGED; NEOPLASMS; PAIN MEASUREMENT; SOLUBILITY; TREATMENT OUTCOME;

ADMINISTRATION, BUCCAL; ADULT; AGED; ANALGESICS, OPIOID; DOSAGE FORMS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; FENTANYL; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; PAIN; PAIN MEASUREMENT; PLACEBOS; SOLUBILITY; TREATMENT OUTCOME;

EID: 77951618928     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdp541     Document Type: Article

References (18)

1. Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain 1990; 41: 273-281.
2. 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.
3. Farrar JT, Cleary J, Rauck R, et al. Oral transmucosal fentanyl citrate: randomized, double-blinded, placebo-controlled trial for treatment of breakthrough pain in cancer patients. J Natl Cancer Inst 1998; 90: 611-616.
4. William L, Macleod R. Management of breakthrough pain in patients with cancer. Drugs 2008; 68: 913-924.
5. Breivik H, Cherny N, Collett B, et al. Cancer-related pain: a pan-European survey of prevalence, treatment, and patient attitudes. Ann Oncol 2009; 20: 1420-1433.
6. Welling P. Pharmacokinetics: Processes, Mathematics and Applications. Washington, DC: American Chemical Society 1997.
7. De Conno F, Groff L, Brunelli C, et al. Clinical experience with oral methadone administration in the treatment of pain in 196 advanced cancer patients. J Clin Oncol 1996; 14: 2836-2842.
8. Zhang H, Zhang J, Streisand JB. Oral mucosal drug delivery: clinical pharmacokinetics and therapeutic applications. Clin Pharmacokinet 2002; 41: 661-680.
9. Vasisht N, Stark J, Finn A. BEMA fentanyl shows a favorable pharmacokinetic profile and dose linearity in healthy volunteers. In 2008 Annual General Meeting of the American Society of Anesthesiologists.
10. Anesta Corp. Actiq (Fentanyl Citrate) Oral Transmucosal Lozenge. Prescribing Information. Revised. Actiq (Fentanyl Citrate) Oral Transmucosal Lozenge [Prescribing information]. Frazer, PA: Cephalon, Inc; 2007.
11. Cephalon Inc. Fentora (Fentanyl Buccal Tablet). Prescribing Information. Revised. Actiq (Fentanyl Citrate) Oral Transmucosal Lozenge [Prescribing information]. Frazer, PA: Cephalon, Inc; 2007.
12. Coluzzi PH, Schwartzberg L, Conroy JD, et al. Breakthrough cancer pain: a randomized trial comparing oral transmucosal fentanyl citrate (OTFC) and morphine sulfate immediate release (MSIR). Pain 2001; 91: 123-130.
13. Vasisht N, Gever LN, Tagarro I, Finn AL. Formulation selection and pharmacokinetic comparison of fentanyl buccal soluble film with oral transmucosal fentanyl citrate: a randomized, open-label, single-dose, crossover study. Clin Drug Investig 2009; 29(10): 647-654.
14. 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.
15. Beecher HK. The powerful placebo. J Am Med Assoc 1955; 159: 1602-1606.
16. Enck P, Benedetti F, Schedlowski M. New insights into the placebo and nocebo responses. Neuron 2008; 59: 195-206.
17. Finniss DG, Benedetti F. Mechanisms of the placebo response and their impact on clinical trials and clinical practice. Pain 2005; 114: 3-6.
18. Benedetti F. Mechanisms of placebo and placebo-related effects across diseases and treatments. Annu Rev Pharmacol Toxicol 2008; 48: 33-60.