title: Effect of fentanyl buccal tablet on pain-related anxiety: a 4-week open-label study among opioid-tolerant patients with chronic and breakthrough pain.
abstract: OBJECTIVE
  To evaluate the effect of fentanyl buccal tablet (FBT) on pain-related anxiety in opioid-tolerant patients with chronic pain and breakthrough pain (BTP).
  
  
  METHODS
  This study consisted of a screening visit, open-label titration period, and 4-week open-label treatment period.
  
  
  METHODS
  Thirty-one US study centers.
  
  
  METHODS
  Opioid-tolerant adults with chronic, persistent pain experiencing 1-4 BTP episodes per day at baseline. Two hundred eighteen patients were enrolled in this study; 180 completed the titration period; and 169 completed the treatment period.
  
  
  METHODS
  Patients were treated with FBT (100-800 microg) for BTP episodes for 4 weeks while continuing their around-the-clock opioid regimens.
  
  
  METHODS
  Change from baseline in the Pain Anxiety Symptoms Scale (PASS) total score at the final visit.
  
  
  RESULTS
  Based on a mean baseline PASS total score of 82.6, study patients had a high level of anxiety; 92 patients (42 percent) had a history of anxiety disorders. The change from baseline in PASS total score was not statistically significant (mean change, -1.6; p = 0.322). Numerical improvements were reported in some secondary measures (eg, Beck Depression Inventory total score /mean change, -1.1; p = 0.038) and categorical measures (eg, Pain Flare Treatment Satisfaction, Patient Assessment of Function, and Clinician Assessment of Patient Function ratings). FBT was generally well tolerated, with no serious adverse events related to study drug.
  
  
  CONCLUSIONS
  Four weeks of treatment with FBT did not reduce anxiety to a clinically meaningful extent, although improvement was reported in several secondary measures of functioning. Further research is needed to assess the impact of treatment for BTP on anxiety symptoms in opioid-tolerant patients with BTP.
authors.affiliation: Salt Lake Regional Medical Center, Salt Lake City, Utah, USA.
authors.forename: Lynn R
authors.initials: LR
authors.lastname: Webster
authors.forename: John
authors.initials: J
authors.lastname: Messina
authors.forename: Fang
authors.initials: F
authors.lastname: Xie
authors.forename: Srinivas
authors.initials: S
authors.lastname: Nalamachu
mesh_terms: D000278:Administration, Buccal; D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D001007:Anxiety / Q000175:diagnosis / Q000209:etiology*; D002908:Chronic Disease; D004361:Drug Tolerance; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D010147:Pain Measurement; D011795:Surveys and Questionnaires; D013607:Tablets; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D000701:Analgesics, Opioid; D013607:Tablets; D005283:Fentanyl