Transdermal Buprenorphine (Transtec^®) in Clinical Practice: An Introduction to Three Short Communications

Data from the International Association on the Study of Pain (IASP) and the European Federation of the IASP Chapters indicate that moderate-to-severe chronic pain affects one in five people, and that one in three are unable, or less able, to maintain an independent lifestyle due to their pain. Approximately 50–60% of people with chronic pain are less able or unable to exercise, enjoy normal sleep, perform household chores, attend social activities, drive a car, walk or have sexual relations [101,102]. Moderate-to-severe chronic pain can be associated with cancer or noncancer conditions (e.g., musculoskeletal, neuropathy and nociceptive pain).

WHO advocates the following three-step ladder for the relief of cancer pain: step 1: nonopioids; step 2: weak opioids, as necessary; step 3: strong opioids, until adequate pain relief is achieved [103].

Buprenorphine, a centrally acting opioid analgesic, binds with high affinity to µ-opioid receptors (agonist) and to κ-opioid receptors (antagonist) [1,2]. Historically, there were concerns relating to a possible analgesic ‘ceiling effect‘ with buprenorphine but these concerns have since been disproved; on the other hand, buprenorphine displays a ceiling effect for respiratory depression, which is a positive safety characteristic [2]. Initially available in parenteral and sublingual formulations, a transdermal buprenorphine patch (Transtec^®, Grünenthal GmbH, Aachen, Germany) was introduced in 2001 [2]. Transtec is available in three dose strengths: 35, 52.5 and 70 µg/h, corresponding to buprenorphine 0.8, 1.2 and 1.6 mg/day, respectively [3,104]. According to the manufacturer‘s labeling, up to two Transtec patches can be combined, equating to buprenorphine doses of up to 140 µg/h or 3.2 mg/day [104]. Buprenorphine is released from the Transtec patch for up to 96 h [3].

Randomized controlled clinical trials established the efficacy and tolerability of transdermal buprenorphine in patients with chronic cancer or noncancer pain [4–6]. These results were subsequently confirmed in several long-term follow-up studies [7], large, prospective, postmarketing surveillance studies in normal clinical practice settings [8,9] and retrospective pharmaco-epidemiological studies [10–12]. In addition, it has been shown that the efficacy and safety of transdermal buprenorphine in elderly patients is similar to that in younger patients [13,14].

The three noninterventional, postmarketing studies reported in this issue as short communications evaluated, under routine clinical conditions, the analgesic effectiveness, safety and tolerability of transdermal buprenorphine in >1600 patients with moderate-to-severe chronic pain. Data were collected and analyzed for patients in whom the use of buprenorphine transdermal patches was medically indicated and planned by treating physicians in routine clinical practice across the Czech Republic (two separate studies: Vondráčková D [15] and Hakl M [16]) and Slovenia (Skvarc NK [17]). As discussed in the following three short communications, these data add to the growing body of evidence in support of the effectiveness and general safety profile of the transdermal buprenorphine patch system.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

The authors thank David P Figgitt PhD, Content Ed Net, for providing editorial assistance in the preparation of this Foreword. Funding for editorial assistance was provided by Grünenthal GmbH, Germany.