Buprenorphine Transdermal Delivery System Research Articles

Perioperative analgesia with a buprenorphine transdermal patch for hallux valgus surgery: a prospective, randomized, controlled study.

PurposeHallux valgus surgery often results in significant postoperative pain. Adequate control of pain is essential for patient satisfaction and improves the outcome of the procedure. This study aimed to investigate the perioperative analgesic effect of a buprenorphine transdermal patch in patients who underwent hallux valgus surgery.Patients and methodsA total of 90 patients were randomly divided into the following three groups based on the perioperative analgesic method: flurbiprofen axetil intravenous injection (Group F), oral celecoxib (Group C), and buprenorphine transdermal delivery system (BTDS) (Group BTDS). The pain status, degree of satisfaction, adverse effects, and administration of tramadol hydrochloride for uncontrolled pain were recorded on the night before surgery, postoperative day 1, postoperative day 2, and postoperative day 3.ResultsThe BTDS could effectively control perioperative pain for patients undergoing hallux valgus surgery. The analgesic effect of the BTDS was better than that of oral celecoxib. In addition, statistically significant differences were not observed in the visual analog scale (VAS) scores, adverse effects, and rescue analgesia between the patients who received the BTDS and the patients who received the flurbiprofen axetil intravenous injection. However, the degree of patient satisfaction of the BTDS group was significantly higher (P<0.05) than that of the other two groups.ConclusionThe BTDS (a preemptive analgesia regimen) could exert an analgesic effect during the perioperative period for patients who had received hallux valgus surgery, and this effect is beneficial for sustaining postoperative physiological and psychological states and promoting functional rehabilitation.

Analysis of the Abuse and Diversion of the Buprenorphine Transdermal Delivery System.

Prescription opioid abuse and diversion are major causes of morbidity and mortality in the United States. The buprenorphine transdermal delivery system (BTDS) is indicated for the treatment of moderate to severe chronic pain and provides a continuous dose of 5, 7.5, 10, 15, or 20μg/h buprenorphine for 7days. Quarterly rates of abuse and diversion of BTDS were compared with 4 comparator groups: 1) other buprenorphine products, 2) fentanyl patches, 3) extended-release (ER) opioid tablets/capsules, and 4) ER tramadol. Data were obtained from the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System Poison Center, Drug Diversion, Treatment Programs Combined (Opioid Treatment and Survey of Key Informants' Patients Programs), and College Survey Programs. Rates were calculated using case counts per population and mentions per prescriptions filled. Poisson regression analysis was used to compare mean rates over time across drug groups after allowing for drug group-specific dispersion parameters. Population adjusted abuse rates were low for BTDS in all of the RADARS System programs compared with the other comparator groups. Findings were similar for the prescription adjusted rates, with BTDS reported at the lowest rates in all programs. Route of abuse differed slightly for BTDS and the comparator groups depending on the program. BTDS was abused and diverted at low rates compared with the other opioid groups in 5 programs of the RADARS System using either population-based rates or prescription dispensed rates. Data from the RADARS System show the BTDS is abused and diverted at low rates compared with other opioid groups including other forms of buprenorphine, fentanyl patches, ER opioid formulations, and ER tramadol.

The Impact of Buprenorphine Transdermal Delivery System on Activities of Daily Living Among Patients With Chronic Low Back Pain

The buprenorphine transdermal delivery system (BTDS) is indicated for reduction of pain in moderate to severe chronic low back pain (CLBP), which can affect patients' ability to perform routine activities of daily living (ADLs). This post hoc analysis of clinical trial data examines the impact of BTDS treatment on CLBP patients' ability to perform ADLs that relate to functioning with low back pain. Data are drawn from a multicenter, enriched enrollment, randomized, placebo-controlled, double-blind 12-week trial of BTDS for pain control among opioid-naive patients with moderate to severe CLBP. The 23 selected ADLs are those that (1) appear in the Low Back Pain Core Set of the International Classification of Functioning, Disability and Health and (2) link to the content of 3 patient-reported outcome instruments administered during the trial. Logistic regression models estimated the odds ratios (ORs) of BTDS patients' ability to perform each ADL at 12 weeks, controlling for baseline ability, relative to placebo. The ORs for 10 ADLs related to sleeping, lifting, bending, and working reached multiplicity-adjusted statistical significance and indicated a greater ability to perform ADLs among BTDS users than among the placebo group. These 10 ORs ranged from 1.9 (no physical health-related restrictions on the kind of work performed) to 2.4 (being able to sleep undisturbed by pain). These results suggest that for patients with moderate to severe CLBP, 12 weeks use of BTDS improves the ability to carry out certain ADLs related to sleeping, lifting, bending, and working.

Poster 45 Survey of Treatment Satisfaction With Buprenorphine Transdermal Delivery System

Poster 45 Survey of Treatment Satisfaction With Buprenorphine Transdermal Delivery System

Poster 46 The Adverse Event Profile of Buprenorphine Transdermal Delivery System in Patients ≥65 and

Poster 46 The Adverse Event Profile of Buprenorphine Transdermal Delivery System in Patients ≥65 and <65 Years of Age

Transdermal Buprenorphine for the Treatment of Chronic Noncancer Pain in the Oldest Old

Context Chronic pain increases with age, and in the elderly, comorbidities and polypharmacotherapy make the choice of treatment for pharmacological pain control a complex matter. Objectives We conducted a multicenter, prospective, observational study to evaluate the efficacy and safety of the buprenorphine transdermal delivery system (TDS) in elderly patients with chronic noncancer pain. The aim was to assess the cognitive and behavioral status of patients during treatment. Methods The study included 93 patients (69 women and 24 men); the mean age was 79.7 years, and in most cases, the pain was due to osteoarthritis. Almost three-quarters (74.2%) of the patients had suffered pain for more than 12 months. The treatment was buprenorphine TDS, starting from a dose of 17.5 μg/h. Outcomes were assessed using the Mini-Mental State Examination (MMSE), the 17-item Hamilton Depression scale (HAM-D 17), the Neuropsychiatric Inventory, the Barthel Index, the Short-Form Health Survey (SF-12), a verbal numeric rating scale, and the Cumulative Illness Rating Scale (CIRS). Results Buprenorphine treatment was associated with a decrease in pain severity without negative effects on the central nervous system. On the HAM-D scale, there were reductions in both the psychological and somatic scores. On the MMSE, values at the beginning and end of the study were comparable. Evaluation by SF-12 showed improvements in physical and mental status. CIRS values at baseline and at the end of the study were superimposable, indirectly confirming the tolerability and safety profile of the drug. Conclusion Our experience confirms the analgesic activity and safety of buprenorphine TDS in the elderly. There was an improvement in mood and a partial resumption of activities, with no influence on cognitive and behavioral ability.

A 6-months, randomised, placebo-controlled evaluation of efficacy and tolerability of a low-dose 7-day buprenorphine transdermal patch in osteoarthritis patients naïve to potent opioids

Objective Patients with osteoarthritis (OA) pain often have insufficient pain relief from non-opioid analgesics. The aim of this trial was to study efficacy and tolerability of a low dose 7-day buprenorphine transdermal delivery system, added to a NSAID or coxib regimen, in opioid-naïve patients with moderate to severe OA pain. Methods A 6 months randomised, double-blind, parallel-group study at 19 centres in Denmark, Finland, Norway, and Sweden, in which OA patients (>40 years) with at least moderate radiographic OA changes and at least moderate pain in a hip and/or knee while on a NSAID or a coxib were randomised to a 7-day buprenorphine patch ( n = 100) or an identical placebo patch ( n = 99). The initial patch delivered buprenorphine 5 μg/h. This was titrated to 10 or 20 μg/h, as needed. Rescue analgesic was paracetamol 0.5–4 g daily. Statistical analysis of outcome data was mainly with a general linear model, with treatment as factor, the primary joint of osteoarthritis, baseline scores, and season as covariates. Results Most patients had OA-radiographic grade II (moderate) or grade III (severe), only 8 in each group had very severe OA (grade IV). The median buprenorphine dose was 10 μg/h. 31 buprenorphine-treated patients and 2 placebo-treated patients withdrew because of side effects. Lack of effect caused 12 placebo-treated and 7 buprenorphine-treated patients to withdraw. The differences in effects between treatments: Daytime pain on movement, recorded every evening on a 0–10 numeric rating scale decreased significantly more (P = 0.029) in the buprenorphine group. Patients’ Global Impression of Change at the end of the double blind period was significantly improved in the buprenorphine group (P = 0.017). The chosen primary effect outcome measure, the Western Ontario and McMaster Universities (WOMAC) OA Index for Pain (P = 0.061), and secondary outcome measures, the WOMAC OA score for functional abilities (P = 0.055), and the WOMAC total score (P = 0.059) indicated more effects from buprenorphine than placebo, but these differences were not statistically significant. In a post-hoc, subgroup analysis with the 16 patients with radiographic grad IV (very severe) excluded, WOMAC OA Index for Pain was significantly (P = 0.039) reduced by buprenorphine, compared with placebo. WOMAC OA score for stiffness and the amount of rescue medication taken did not differ. Sleep disturbance, quality of sleep, and quality of life improved in both groups. Side effects: Typical opioid side effects caused withdrawal at a median of 11 days before completing the 168 days double blind trial in 1/3 of the buprenorphine group. Mostly mild local skin reactions occurred equally often (1/3) in both groups. Conclusions Although the 24 hours WOMAC OsteoArthritis Index of pain was not statistically significantly superior to placebo, day-time movement-related pain and patients’ global impression of improvement at the end of the 6-months double blind treatment period were significantly better in patients treated with buprenorphine compared with placebo. Opioid side effects caused 1/3 of the buprenorphine-patients to withdraw before the end of the 6-months double blind study period. Implications A low dose 7-days buprenorphine patch at 5–20 μg/h is a possible means of pain relief in about 2/3 of elderly osteoarthritis patients, in whom pain is opioid-sensitive, surgery is not possible, NSAIDs and coxibs are not recommended, and paracetamol in tolerable doses is not effective enough. Vigilant focus on and management of opioid side effects are essential.

Treatment of Ischemic Pain in Patients Suffering from Peripheral Vasculopathy with Transdermal Buprenorphine Plus Epidural Morphine with Ropivacaine vs. Epidural Morphine with Ropivacaine

This study compared the efficacy and safety of buprenorphine transdermal delivery system with peridural infusion of morphine and ropivacaine to peridural infusion alone for the control of ischemic pain in patients suffering from peripheral vasculopathy. Eighty-six patients were randomized into two groups. In the first group, a buprenorphine patch 35 microg/hour TTDS (transtec transdermal device plus ropivacaine and morphine) was applied, and a peridural infusion of ropivacaine/morphine (200 mg + 2 mg) was established. In the second group, ropivacaine and morphine analgesia was obtained using a peridural infusion and a placebo patch. The primary efficacy parameter was the visual analog scale score for pain. Secondary parameters of efficacy were the short-form McGill Pain Questionnaire scores and a score for pain interference with sleep obtained from patient diaries evaluated every week for a period of 4 weeks. Subjects in the TTDS group reported a reduction in pain, increased sleep, and a lower incidence of side effects compared with the control group. Transdermal buprenorphine use resulted in significant pain relief with excellent patient satisfaction, which may translate into improvement in mood and quality of life.

Short‐ and intermediate‐term efficacy of buprenorphine TDS in chronic painful neuropathies

Buprenorphine is a potent opioid available as a transdermal delivery system (TDS) formulation. This open-label study investigated its safety, tolerability, and efficacy in 30 patients with chronic painful neuropathy. Subjects with visual analogue scale (VAS) score > or = 5 under stable analgesic treatment were entered. The starting dosage of 35 microg/h was increased up to 70.0 microg/h in case of unsatisfactory pain control as assessed by fortnightly visits. The primary endpoint was the number of patients achieving at least 30% pain relief at day 42 visit. Treatment was safe over the study period. Nine patients dropped out for side effects, mostly nausea and daily sleepiness. Buprenorphine TDS was well tolerated in 21 patients. Thirteen patients achieved > 30% of pain relief at day 42 visit. Five patients needed to increase the dosage to 52.5 microg/h. Eight patients did not meet the primary outcome, but none allowed increasing the dosage to 70 microg/h, and four patients withdrew consent to continue the study before day 42 visit because of a 'fear to become addicted,' although 40% had obtained VAS reduction. In our study, which needs to be confirmed by a controlled trial, buprenorphine TDS induced clinically meaningful pain relief in about 40% of patients with chronic painful neuropathy, suggesting its use as a third-line treatment.

Buprenorphine Transdermal Delivery System in Adults with Persistent Noncancer-Related Pain Syndromes Who Require Opioid Therapy: A Multicenter, 5-Week Run-in and Randomized, Double-Blind Maintenance-of-Analgesia Study

Objective: This study compared the efficacy and safety profile of buprenorphine transdermal delivery system (BTDS) and placebo in subjects with persistent noncancer-related pain who required opioid analgesics. Methods: This was a multicenter, double-blind, parallel-group study in adult subjects (age ≥18 years) with at least a 2-month history of noncancer-related pain for which they received oral opioid combination agents. The study employed a maintenance-of-analgesia, or randomized-withdrawal, design. During a 7- to 21-day open-label run-in phase, all subjects received BTDS, titrated as needed. Subjects who achieved stable pain control and were able to tolerate BTDS in the run-in phase were randomly assigned to continue BTDS at the dose achieved during the run-in phase or to receive placebo for up to 14 days. Acetaminophen 500-mg tablets were provided as escape (rescue) medication. Subjects completed the study on day 14 or when they met predefined criteria for ineffective treatment: requiring >1 g of acetaminophen as escape medication on any day of the double-blind evaluation phase, requiring a change in study drug dose, having difficulty keeping the patch affixed, or discontinuing because of ineffective treatment without meeting any of the first 3 criteria. The primary efficacy variable was the proportion of subjects with ineffective treatment. Secondary efficacy variables were the time to ineffective treatment; the proportion of subjects who reached ineffective treatment or discontinued for any reason other than ineffective treatment; and the amount of escape medication used. Assessment of the safety profile was based on adverse events and changes in vital signs and physical and laboratory findings. Results: Five hundred eighty-eight subjects entered the open-label run-in phase, and 267 (129 BTDS, 138 placebo) were subsequently randomized to doubleblind treatment. Demographic characteristics were similar between the double-blind BTDS and placebo groups (61.2% and 63.8% female, respectively; 99.2% and 98.6% white; mean [SD] age, 56.2 [13.3] and 59.2 [11.5] years). In the primary efficacy analysis, the proportion of subjects with ineffective treatment was lower with BTDS than with placebo (51.2% vs 65.0%; 95% CI, 1.09-2.95); the odds of ineffective treatment were 1.79 times greater for placebo relative to BTDS (P = 0.022). In the secondary efficacy analyses, the median time from the first dose of double-blind study drug to ineffective treatment was significantly longer with BTDS than with placebo (median, 10 vs 3 days; P = 0.011). The proportion of subjects who reached ineffective treatment or discontinued for reasons other than ineffective treatment was lower in the BTDS group compared with the placebo group (55.0% vs 67.9%); the odds of ineffective treatment or discontinuation for a reason other than ineffective treatment was 1.76 times greater with placebo compared with BTDS (P = 0.028). The mean amount of escape medication used was significantly lower in the BTDS group than in the placebo group (1.7 vs 2.2 acetaminophen tablets per day; P = 0.015). The most common adverse events in the open-label run-in or double-blind phase occurring at a higher incidence with BTDS than with placebo were pruritus at the patch application site (9.3% vs 5.1%, respectively), headache (3.9% vs 2.2%), and somnolence (2.3% vs 0.7%). Conclusion: In this population of adult subjects with persistent noncancer-related pain who required opioid therapy, BTDS use was associated with analgesic efficacy and was generally well tolerated. Results of this study were presented in part at the annual meeting of the American Pain Society, March 30-April 2, 2005, Boston, Massachusetts.

Effectiveness and tolerability of the buprenorphinetransdermal system in patients with moderate to severe chronic pain: A multicenter, open-label, uncontrolled, prospective, observational clinical study

Background: A new transdermal delivery system (TDS) for the rate-controlled systemic delivery of buprenorphine is available in 3 patch strengths, with release rates of 35, 52.5, and 70 μg/h over 72 hours, delivering daily amounts of 0.8, 1.2, and 1.6 mg, respectively. Randomized, double-blind, placebo-controlled, Phase III clinical trials in >400 patients with severe pain of malignant or nonmalignant origin have shown the analgesic efficacy of buprenorphine TDS. Objective: This study investigated the effectiveness and tolerability of buprenorphine TDS for the relief of chronic pain in routine clinical practice. Methods: This was a multicenter, open-label, uncontrolled, prospective, observational, 3-month follow-up study in patients who were beginning buprenorphine TDS treatment for moderate to severe cancer or noncancer pain that had not responded to nonopioid analgesics. Patches were to be changed every 72 hours. Patients were evaluated at 1 and 3 months after the start of treatment. Those who dropped out were considered treatment failures. Pain relief was assessed on a 5-category verbal rating scale, and quality of life was assessed using the European Quality of Life 5D (EQ-5D) questionnaire. Tolerability was determined based on adverse events recorded during the follow-up period. Results: The study recruited 1223 patients, most of whom were outpatients. Of the 1212 patients for whom sex data were available, 820 (67.7%) were women. In the 1188 patients with age data, the mean (SD) age was 64.9 (12.9) years. In the 1175 patients with data on the etiology of pain, 82.4% had noncancer pain. Six hundred eighty-eight (56.3%) patients completed the 3-month follow-up period. The median daily amount of buprenorphine TDS received at the beginning of the study was 0.8 mg (corresponding to 35 μg/h). Over the study period, there was a significant increase in the proportion of patients reporting very good or good pain relief ( P < 0.001), from 3.6% (43/1205) at baseline to 63.2% (762/1205) after 1 month and 56.8% (685/1205) after 3 months. Quality of life also improved, from a mean (SD) EQ-5D score of 40.6 (20.5) at baseline to 56.8 (23.5) at 3 months ( P < 0.001). Five hundred seventeen (42.3%) of the original 1223 patients experienced adverse events; the investigator judged 397 (32.5%) of these events possibly or probably related to study drug. The likelihood of experiencing a drug-related adverse event was greater in noncancer patients than in cancer patients. The most common adverse events were nausea (11.0%), vomiting (9.2%), and constipation (7.8%); the most common local adverse events were pruritus (1.4%), dermatitis (1.3%), and erythema (1.3%). Conclusion: In the population studied, buprenorphine TDS was effective in alleviating cancer and noncancer pain and was well tolerated overall.

Effectiveness of 7-day busprenorphine transdermal system in the management of chronic nonmalignant pain syndromes

This multicenter (21 UK, 21 US), randomized, double-blind, parallel-group study compared the efficacy and safety of a 7-day buprenorphine transdermal delivery system (BTDS) with placebo transdermal delivery system (PLTDS) in patients with persistent nonmalignant pain requiring combination opioid therapy, using a maintenance of analgesia design. Patients who met stable pain control criteria on BTDS 5, 10, or 20 during an open-label run-in period, were randomized to PLTDS (N = 138) or BTDS (N = 129) at the dose providing stable pain control. End of study was on Day 14 or when patients experienced ineffective treatment. Patients who reached ineffective treatment were PLTDS (65%), BTDS (51%). The odds of ineffective treatment were 1.8 times greater with PLTDS (P = .0217). The median time from first dose of double-blind study drug to ineffective treatment was significantly longer for BTDS compared with PLTDS (10 days vs 3 days). Exploratory analyses did not reveal an influence of potential opioid withdrawal symptoms postrandomization on the time to ineffective treatment. There were no deaths. Nine patients had adverse events that led to discontinuation in the double-blind phase (PLTDS 4; BTDS 5). The incidence of adverse events during the double-blind phase was higher for patients receiving BTDS (48%), compared with PLTDS (40%). Common adverse events reported were erythema at application site (PLTDS 13%; BTDS 13%), and pruritus at site (PLTDS 5%; BTDS 9%). This study supports the efficacy, safety, and tolerability of 7-day BTDS in patients with persistent nonmalignant pain who require opioid therapy. Purdue Pharma, L.P. provided financial support.

Transdermal buprenorphine in the treatment of chronic pain: Resultsof a phase III, multicenter, randomized, double-blind, placebo-controlled study

Background: Buprenorphine, a potent opioid analgesic, has been available in parenteral and oral or sublingual(SL) formulations for >25 years. In 2001, the buprenorphine transdermal delivery system (TES) was introduced at 3 release rates (35, 52.5, and 70 μg/h) for the treatment of chronic cancer and noncancer pain. Objective: This study compared the analgesic efficacy and tolerability of buprenorphine TES at a release rateof 35 μg/h with those of buprenorphine SL and placebo in patients with severe or very severe chronic cancer or noncancer pain. Methods: This multicenter, double-blind, placebo-controlled, parallel-group trial was 1 of 3 Phase III studies involved in the clinical development of buprenorphine TDS. It comprised a 6-day open-label run-in phase in which patients received buprenorphine SL 0.8 to 1.6 mg/d as needed and a double-blind phase in which patients were randomized to receive 3 sequential patches containing buprenorphine TES 35 μg/h or placebo, each lasting 72 hours. Rescue analgesia consisting of buprenorphine SL 02-mg tablets was available as needed throughout the double-blind phase. The main outcome measures were (1) the number of buprenorphine SL tablets required in addition to buprenorphine TES during the double-blind phase compared with the placebo group and compared with the buprenorphine SL requirement during the run-in phase, and (2) patients' assessments of pain intensity, pain relief, and duration of sleep uninterrupted by pain in the double-blind phase compared with the run-in phase. Adverse events were documented throughout the study Results: One hundred thirty-seven patients were included in the double-blind phase (90 buprenorphine TES,47 placebo). The buprenorphine TES group included 47 men and 43 women (mean [SD] age, 56.0 [12.1] years), and the placebo group included 23 men and 24 women (mean age, 55.7 [12.9] years). Forty-five patients had cancer-related pain and 92 had noncancer-related pain. The 2 treatment groups were comparable with respect to sex distribution, age, height, and body weight Patients receiving buprenorphine TES significantly reduced their consumption of buprenorphine SL tablets in the double-blind phase compared with patients receiving placebo (reduction of 0.6 [0.4] mg vs 0.4 [0.4] mg; P = 0.03). The relationship between the buprenorphine SL dose in the run-in phase and the number of buprenorphine SL tablets required in the double-blind phase was dose dependent in the active-treatment group only. Patients' assessments of pain intensity and pain relief suggested better analgesia with buprenorphine TES than with placebo, although the differences did not reach statistical significance. The proportion of patients who reported sleeping for >6 hours uninterrupted by pain in the double-blind phase compared with the run-in phase increased by 6.4% in the buprenorphine TDS group (35.6% vs 292%, respectively), compared with a decrease of 5.9% in the placebo group (40.4% vs 463%); no statistical analysis of sleep duration data was performed. Buprenorphine TDS was well tolerated, with adverse events generally similar to those associated with other opioids. The incidence of systemic adverse events in the double-blind phase was similar in the 2 treatment groups (28.9% buprenorphine TDS, 27.6% placebo), with the most common adverse events being nausea, dizziness, and vomiting. After patch removal, skin reactions (mainly mild or moderate pruritus and erythema) were seen in 35.6% of the buprenorphine TDS group and 25.5% of the placebo group. Conclusions: In the population studied, buprenorphineTDS provided adequate pain relief, as well as improvements in pain intensity and duration of pain-free sleep. It may be considered a therapeutic option for the treatment of moderate to severe chronic pain.

Analgesic efficacy and tolerability of transdermal buprenorphine in patients with inadequately controlled chronic pain related to cancer and other disorders: A multicenter, randomized, double-blind, placebo-controlled trial

Background: Buprenorphine is a potent opioid analgesic that is available in sublingual and parenteral formulations. A new formulation, buprenorphine transdermal delivery system (TDS), has been developed. Objective: The aim of this study was to compare the analgesic efficacy and tolerability of the 3 available dosages of buprenorphine TDS (35.0, 52.5, and 70.0 μg/h) with placebo. Methods: This was a randomized, double-blind, placebo-controlled, multicenter study. Patients with chronic, severe pain related to cancer or other diseases and inadequately controlled with weak opioids were randomized to receive buprenorphine TDS 35.0, 52.5, or 70.0 μg/h or placebo patch for up to 15 days. A new patch was applied every 72 hours, for a total of 5 patches. All patients were permitted rescue analgesia with sublingual buprenorphine tablets (0.2 mg) as required for breakthrough pain. Results: A total of 157 patients (86 women, 71 men; mean [SD] age, 58.7 [11.8] years) were initially enrolled in the study. Buprenorphine TDS was associated with significantly higher response rates than was placebo at the 35.0- and 52.5-μg/h dosages (36.6% and 47.5%, respectively, vs 16.2%; P=0.032 and P=0.003, respectively) and a numerically higher response rate at 70.0 μg/h (33.3%), although this difference did not reach statistical significance. Patients treated with buprenorphine TDS experienced a 56.7% reduction in use of sublingual rescue analgesic during the study compared with an 8% reduction with the placebo patch. A total of 43.5% of patients treated with buprenorphine TDS reported good or complete pain relief compared with 32.4% in the placebo group. Pain intensity decreased in a dose-dependent manner with buprenorphine TDS, and the duration of sleep uninterrupted by pain was improved by the end of the study. More than three fourths (78.8%) of patients in the placebo and buprenorphine TDS groups reported at least 1 adverse event (AE) during the study. The most common AEs were central nervous system and gastrointestinal symptoms. The majority of treatment-related AEs were mild or moderate in intensity and were typical of those occurring at the beginning of therapy with a strong opioid. Conclusions: Buprenorphine TDS was shown to be an effective analgesic against chronic, severe pain in this study population. Patients treated with this new formulation of buprenorphine showed improved duration of sleep and reduced need for additional oral analgesics.