title: Application site adverse events associated with the buprenorphine transdermal system: a pooled analysis.
abstract: OBJECTIVE
  To characterize the profile of application site reactions (ASRs) for patients treated with the buprenorphine transdermal system (BTDS) in chronic pain studies.
  
  
  METHODS
  The incidences of ASRs during treatment with BTDS were examined using (a) integrated data from 16 controlled and uncontrolled Phase III chronic pain studies (N = 6566), (b) a subset of integrated data that focused on the double-blind phases of five enriched, placebo-controlled studies (n = 1806) and (c) data from an international postmarketing drug safety database. These data were compared with the ASR data reported in the full prescribing information of other transdermal patches marketed in the US.
  
  
  RESULTS
  Among the 6566 patients, the overall incidence of ASRs was 23.4%, of which 98.3% were mild to moderate in intensity, none were serious and 4.4% led to treatment discontinuation. Rates of severe and inflammatory ASRs were low. Among the 1806 patients, ASR rates were higher with BTDS (16.6%) than placebo transdermal system (12.7%). Among the 6566 patients, the 1806 patients, and the postmarketing data, the most common ASRs seen were pruritus, erythema and rash. Incidences of most ASRs for other selected transdermal products were 17% or lower.
  
  
  CONCLUSIONS
  Incidence rates of ASRs in patients treated with BTDS were low and infrequently led to discontinuation. Severe and inflammatory-type ASRs were not common. The ASR profile of BTDS was comparable with those of other transdermal patches.
authors.affiliation: Purdue Pharma LP, One Stamford Forum, 7th Floor, Stamford, CT 06901, USA. Warren.Wen@pharma.com
authors.forename: Warren
authors.initials: W
authors.lastname: Wen
authors.forename: Shau Yu
authors.initials: SY
authors.lastname: Lynch
authors.forename: Catherine
authors.initials: C
authors.lastname: Munera
authors.forename: Ruth
authors.initials: R
authors.lastname: Swanton
authors.forename: Steven R
authors.initials: SR
authors.lastname: Ripa
authors.forename: Howard
authors.initials: H
authors.lastname: Maibach
mesh_terms: D000279:Administration, Cutaneous; D000368:Aged; D002047:Buprenorphine / Q000008:administration & dosage* / Q000009:adverse effects*; D059350:Chronic Pain / Q000188:drug therapy; D017326:Clinical Trials, Phase III as Topic; D017449:Dermatitis, Allergic Contact / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D057968:Transdermal Patch / Q000009:adverse effects*
chemical_list: D002047:Buprenorphine