Buprenorphine TDS: the clinical development rationale and results.

Abstract	Buprenorphine, a powerful opioid, is newly available for delivery in a transdermal formulation. The transdermal system's matrix patch provides rate-controlled administration of the drug. Three double-blind, placebo-controlled trials were conducted to evaluate efficacy and tolerability of the buprenorphine transdermal system (buprenorphine TDS, Transtec). A total of 445 patients were enrolled in the studies. All suffered from moderate to severe and very severe pain, both cancer- or non-cancer-related. The percentage of responders increased as the rate of buprenorphine delivered by the transdermal system rose, ranging from a 29% (cancer) and 36% (non-cancer) response rate associated with the lowest dose (35 microg/h), to 40% (cancer) and 46% (non-cancer) with the highest dose (70 microg/h). Patients receiving buprenorphine TDS slept longer, uninterrupted by pain, than patients from the placebo group. Systemic adverse effects reported in the drug cohorts included nausea, vomiting and dizziness, and were typical of those reported in other studies of opioids; local adverse events, most commonly erythema and pruritus, were transient and mild to moderate. In an open-label, follow-up trial, in which 239 patients from the original clinical studies participated, 90% of patients reported that their analgesia was satisfactory or even better over a mean duration of 4.7 months; nearly 95% of patients found the patch to be user-friendly. The new buprenorphine TDS appears to be an important new modality for administering analgesia in patients with non-acute pain.
Authors	Lukas Radbruch, Ans Vielvoye-Kerkmeer
Journal	International journal of clinical practice. Supplement (Int J Clin Pract Suppl) Issue 133 Pg. 15-8; discussion 23-4 (Feb 2003) ISSN: 1368-504X [Print] England
PMID	12665119 (Publication Type: Journal Article, Review)
Chemical References	Analgesics, Opioid Buprenorphine
Topics	Analgesics, Opioid (administration & dosage, adverse effects) Attitude to Health Buprenorphine (administration & dosage, adverse effects) Humans Multicenter Studies as Topic Pain (prevention & control, psychology) Randomized Controlled Trials as Topic Treatment Outcome

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.

Realize the full power of the drug-disease research graph!