Long-term safety, tolerability, and consistency of effect of fentanyl pectin nasal spray for breakthrough cancer pain in opioid-tolerant patients

Journal of Opioid Management

Volumn 6, Issue 5, 2010, Pages 319-328

  Portenoy, Russell K ^a   Raffaeli, William ^b   Torres, Luis M ^c   Sitte, Thomas ^d   Deka, Akhil Chandra ^e   Herrera, Ileana Gonzalez ^f   Wallace, Mark S ^g  

^a BETH ISRAEL MEDICAL CENTER   (United States)

^b Infermi Hospital   (Italy)

^c HOSPITAL UNIVERSITARIO PUERTA DEL MAR   (Spain)

^d PalliativNetz Osthessen   (Germany)

^e Karnataka Cancer Therapy and Research Institute   (India)

^f Hospital Clinica Santa Rita   (Costa Rica)

^g University of California at San Diego   (United States)

Author keywords

Breakthrough cancer pain; Fentanyl; Intranasal

Indexed keywords

CODEINE; FENTANYL; HYDROCODONE; HYDROMORPHONE; METHADONE; MORPHINE; OPIATE; OXYCODONE; PECTIN; NARCOTIC ANALGESIC AGENT;

ADULT; AEROSOL; AGED; AIRWAY OBSTRUCTION; ARTICLE; BREAKTHROUGH CANCER PAIN; CANCER PAIN; CANCER PATIENT; CAUSE OF DEATH; CLINICAL TRIAL; CONFUSION; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; CYANOSIS; DISEASE EXACERBATION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; EPISTAXIS; EUPHORIA; FEMALE; HEADACHE; HUMAN; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NOSE CONGESTION; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RHINORRHEA; SIDE EFFECT; SOMNOLENCE; SORE THROAT; TASTE DISORDER; TREATMENT OUTCOME; UNCONSCIOUSNESS; VOMITING; CHRONIC DISEASE; DRUG TOLERANCE; INTRACTABLE PAIN; INTRANASAL DRUG ADMINISTRATION; MIDDLE AGED; NEOPLASM; PATHOPHYSIOLOGY; PROSPECTIVE STUDY;

ADMINISTRATION, INTRANASAL; ADULT; AGED; ANALGESICS, OPIOID; CHRONIC DISEASE; DRUG TOLERANCE; FEMALE; FENTANYL; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; PAIN, INTRACTABLE; PECTINS; PROSPECTIVE STUDIES;

EID: 78349255839     PISSN: 15517489     EISSN: None     Source Type: Journal    
DOI: 10.5055/jom.2010.0029     Document Type: Article

References (26)

1. Davies AN, Dickman A, Reid C, et al.: The management of cancer-related breakthrough pain: Recommendations of a task group of the Science Committee of the Association for Palliative Medicine of Great Britain and Ireland. Eur J Pain. 2009; 13: 331-338.
2. Svendsen KB, Andersen S, Arnason S: Breakthrough pain in malignant and non-malignant diseases: A review of prevalence, characteristics and mechanisms. Eur J Pain. 2005; 9: 195-206.
3. Portenoy R, Bruns D, Shoemaker B, et al.: Breakthrough pain in community-dwelling patients with cancer pain and non-cancer pain, Part 1: Prevalence and characteristics. J Opioid Manag. 2010; 6: 97-108.
4. Portenoy RK, Payne D, Jacobsen P: Breakthrough pain: Characteristics and impact in patients with cancer pain. Pain. 1999; 81: 129-134.
5. 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.
6. Portenoy R, Bruns D, Shoemaker B, et al.: Breakthrough pain in community-dwelling patients with cancer pain and non-cancer pain, Part 2: Impact on function, mood, and quality of life. J Opioid Manag. 2010; 6: 109-116.
7. Fortner BV, Demarco G, Irving G, et al.: Description and predictors of direct and indirect costs of pain reported by cancer patients. J Pain Symptom Manage. 2003; 25: 9-18.
8. Fortner BV, Okon TA, Portenoy RK: A survey of pain-related hospitalizations, emergency department visits, and physician office visits reported by cancer patients with and without history of breakthrough pain. J Pain. 2002; 3: 38-44.
9. Abernethy AP, Wheeler JL, Fortner BV: A health economic model of breakthrough pain. Am J Manag Care. 2008; 14 (Suppl 1): S129-S140.
10. Zeppetella G, Ribeiro MD: Opioids for the management of breakthrough (episodic) pain in cancer patients. Cochrane Database Syst Rev. 2006; (1): CD004311.
11. 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.
12. 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; 22: 805-811.
13. 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; 5: 327-334. (Pubitemid 350055013)
14. Vasisht N, Gever LN, Tagarro I, et 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: 647-654.
15. 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.
16. Davies A, Broadley K, Beighton D: Xerostomia in patients with advanced cancer. J Pain Symptom Manage. 2001; 22: 820-825.
17. Davies A, Vriens J: Oral transmucosal fentanyl citrate and xerostomia. J Pain Symptom Manage. 2005; 30: 496-497.
18. Jacobsen R, Moldrup C, Christrup L: Clinical rationale for administering fentanyl to cancer pain patients: Two Delphi surveys of pain management experts in Denmark. J Opioid Manag. 2008; 4: 383-391.
19. Dale O, Hjortkjaer R, Kharasch ED: Nasal administration of opioids for pain management in adults. Acta Anaesthesiol Scand. 2002; 46: 759-770.
20. Ilium L: Nasal drug delivery - Possibilities, problems and solutions. J Control Release. 2003; 87: 187-198.
21. Watts P, Smith A: PecSys: In situ gelling system for optimised nasal drug delivery. Expert Opin Drug Deliv. 2009; 6: 543-552.
22. Lennernäs B, Hedner T, Holmberg M, et al.: Pharmacokinetics and tolerability of different doses of fentanyl following sublingual administration of a rapidly dissolving tablet to cancer patients: A new approach to treatment of incident pain. Br J Clin Pharmacol. 2004; 59: 249-253.
23. Portenoy R, Burton AW, Gabrail N, et al.: A multicenter, placebo-controlled, double-blind, multiple-crossover study of fentanyl pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain. Pain. (in press).
24. Fallon M, Gatti A, Davies AN, et al.: Efficacy, safety and patient acceptability of fentanyl pectin nasal spray compared with immediate-release morphine sulphate tablets in the treatment of breakthrough cancer pain: A multicentre, double-blind, doubledummy, multiple-crossover study. Eur J Cancer Supp. 2009; 7: 15.
25. Bennett DS, Burton AW, Fishman S, et al.: Consensus panel recommendatios for the assessment and management of breakthrough pain, Part 2: Management. Pharm Ther. 2005; 30: 354-361. (Pubitemid 40885216)
26. Walker G, Wilcock A, Manderson C, et al.: The acceptability of different routes of administration of analgesia for breakthrough pain. Palliat Med. 2003; 17: 219-221.