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

Volumn 115, Issue 11, 2009, Pages 2571-2579

  Weinstein, Sharon M ^a   Messina, John ^b   Xie, Fang ^b  

^a UNIVERSITY OF UTAH   (United States)

^b CEPHALON INC   (United States)

Author keywords

Breakthrough pain; Cancer pain; Fentanyl buccal tablet; Long term therapy; Opioid; Safety; Tolerability

Indexed keywords

FENTANYL; FENTANYL CITRATE; HYDROCODONE BITARTRATE PLUS PARACETAMOL; HYDROMORPHONE; METHADONE; MORPHINE; OXYCODONE;

ABDOMINAL PAIN; ADULT; AGED; ANEMIA; ANOREXIA; ANXIETY; APPLICATION SITE REACTION; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; CANCER PAIN; CHRONIC PAIN; CLINICAL TRIAL; CONFUSION; CONSTIPATION; COUGHING; DEHYDRATION; DEPRESSION; DIARRHEA; DIZZINESS; DRUG DOSE TITRATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; DYSPNEA; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; HYPESTHESIA; HYPOKALEMIA; HYPOTENSION; INSOMNIA; MAINTENANCE DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MORPHINE TOLERANCE; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; OPEN STUDY; PATIENT COMPLIANCE; PERIPHERAL EDEMA; PNEUMONIA; PRIORITY JOURNAL; PRURITUS; SIDE EFFECT; SOMNOLENCE; SORE THROAT; STOMATITIS; TABLET FORMULATION; URINARY TRACT INFECTION; VOMITING; WEIGHT REDUCTION;

ADMINISTRATION, BUCCAL; ANALGESICS, OPIOID; CHRONIC DISEASE; DISEASE PROGRESSION; DRUG TOLERANCE; FEMALE; FENTANYL; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; PAIN; TIME FACTORS;

EID: 66649114524     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.24279     Document Type: Article

References (16)

1. Bennett D, Burton A, Fishman S, et al. Consensus panel recommendations for the assessment and management of breakthrough pain. Part 1: Assessment. Pharm Ther. 2005;30:296-301.
2. Caraceni A, Martini C, Zecca E, et al; Working Group of an IASP Task Force on Cancer Pain. Breakthrough pain characteristics and syndromes in patients with cancer pain. An international survey. Palliat Med. 2004;18:177-183.
3. Portenoy RK, Payne D, Jacobsen P. Breakthrough pain: characteristics and impact in patients with cancer pain. Pain. 1999;81:129-134. (Pubitemid 29199908)
4. Miaskowski C, Cleary J, Burney R, et al. Guideline for the management of cancer pain in adults and children. APS Clinical Practice Guidelines Series, No. 3. Glenview, IL: American Pain Society; 2005.
5. Zeppetella G, Ribeiro MD. Opioids for the management of breakthrough (episodic) pain in cancer patients. Cochrane Database Syst Rev. 2006;(1):CD004311.
6. Levy MH. Pharmacologic treatment of cancer pain. N Engl J Med. 1996;335:1124-1132.
7. Bennett D, Burton AW, Fishman S, et al. Consensus panel recommendations for the assessment and management of breakthrough pain. Part 2: Management. Pharm Ther. 2005; 30:354-361.
8. Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain. 1990;41:273-281. (Pubitemid 20187930)
9. Zeppetella G, O'Doherty CA, Collins S. Prevalence and characteristics of breakthrough pain in cancer patients admitted to a hospice. J Pain Symptom Manage. 2000;20:87-92.
10. Mercadante S, Radbruch L, Caraceni A, et al. Episodic (breakthrough) pain: consensus conference of an expert working group of the European Association for Palliative Care. Cancer. 2002;94:832-839. (Pubitemid 34132314)
11. Hwang SS, Chang VT, Kasimis B. Cancer breakthrough pain characteristics and responses to treatment at a VA medical center. Pain. 2003;101:55-64. (Pubitemid 36044654)
12. Durfee S, Messina J, Khankari R. Fentanyl effervescent buccal tablets: enhanced buccal absorption. Am J Drug Deliv. 2006;4:1-5.
13. 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. (Pubitemid 44627444)
14. Slatkin NE, Xie F, Messina J, Segal TJ. Fentanyl buccal tablet for relief of breakthrough pain in opioid-tolerant patients with cancer-related chronic pain: a double-blind, randomized, placebo-controlled study. J Support Oncol. 2007;5:327-334.
15. International Conference on Harmonisation Expert Working Group. ICH harmonised tripartite guideline: guideline for good clinical practice E6(R1). 1996. Available at: http://www.ich.org/LOB/media/MEDIA482.pdf. Accessed on March 30, 2009.
16. Collett BJ. Opioid tolerance: the clinical perspective. Br J Anaesth. 1998;81:58-68. (Pubitemid 28359266)