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F609 PATIENT SATISFACTION DURING TREATMENT WITH SUBLINGUAL FENTANYL FOR BREAKTHROUGH CANCER PAIN
POSTER SESSIONS / European Journal of Pain Supplements 5 (2011) 15–295
Conclusions: We believe; the ultrasound guided 3–1 block and particularly FICB are parts of multimodal analgesic treatment in order to enable postoperative analgesia and these methods should be employed as a safe and efficient way. Disclosure: None declared
F607 A PERSONALIZED APPROACH TO POSTOPERATIVE PAIN IN DAY CARE SETTING: TWO YEAR FOLLOW-UP ON THE ANTWERP PERSONALIZED PAIN INITIATIVE G.H. Hans1,2 *, J. Leys3 , L. Sermeus1,2 , M. Vercauteren1,2 . 1 Multidisciplinary Pain Center (PCT), Antwerp University Hospital (UZA), 2 Department of Anesthesiology, 3 Department of Pharmacy, University Hospital of Antwerp (UZA), Edegem, Belgium Background and Aims: Chronification of pain after surgery is a recognised medical problem. However, little is known concerning the development of chronic pain after day care surgery. These patients quickly leave the hospital, receiving only minimal amounts of weak analgesics. To respond to this shortcoming, the Antwerp Personalised Pain Initiative was established. Methods: In a first phase of the project, incidence and intensity of postoperative pain was identified for diverse day care surgical procedures (total of 250 patients). It became evident that certain surgical procedures induce severe pain in up to 70% of patients, while other surgical procedures almost never induce moderate to severe pain. Additionally, an analysis of patient characteristics that negatively influence the risk of prolonged postoperative pain was carried out. Results: After identifying “high risk” surgical procedures and patient groups, an individualized approach to postoperative pain management was implemented. Based on personal characteristics of the patient and type of surgery that the patient is scheduled for, a patient-specific “risk-score” is composed. Based on this score an individualized pain management schedule is initiated. Upon discharge, the patient receives an “analgesic kit” (9 different kits were composed) containing a treatment for 3 up to 7 days (depending on patient’s total risk-score). Moreover, the patient has the possibility to invoke specialist advice via a dedicated telephone number. Conclusions: The progressive implementation of this project has resulted in a significant decrease of pain after day care surgery and highly increased patient satisfaction. Progress information over 2 yr period is provided.
171
across all subgroups. Moreover, younger patients (<50 years) experienced greater interference of pain with sleep, versus older patients (p = 0.001), and depression was greater in women versus men (p = 0.004). Improvements in several measures of pain and functioning were greater in patients who successfully titrated and were treated in the maintenance phase, compared to those who withdrew (p≤0.005 for pain relief, least pain and interference with sleep). Conclusions: This new analysis confirms that BTcP has detrimental impacts of quality of life, particularly in younger patients and women. The findings indicate that successful titration and continued therapy with an effective analgesic is important for improving pain and functioning. This study was sponsored by ProStrakan Group Ltd. Disclosure: The study was sponsored by ProStrakan Group Ltd. JH is an employee of ProStrakan. Assistance with preparation of this abstract was provided by Acumen Healthcare Communications, supported by ProStrakan.
F609 PATIENT SATISFACTION DURING TREATMENT WITH SUBLINGUAL FENTANYL FOR BREAKTHROUGH CANCER PAIN R. Rauck1 , M. Wallace2 , S. Nalamachu3 , D. Hassman4 , J. Howell5 *. 1 Carolinas Pain Institute Center for Clinical Research, Winston Salem, NC, 2 Center for Pain Medicine, University of California, San Diego, CA, 3 International Clinical Research Institute, Overland Park, KS, 4 Berlin Medical Associates, Berlin, NJ, USA; 5 ProStrakan Group Plc, Galashiels, UK Background and Aims: Sublingual fentanyl tablets (SLF, Abstral® ) have demonstrated efficacy for treatment of breakthrough cancer pain (BTcP) in opioid-tolerant patients. Evaluations of patients’ satisfaction with medication provide important measures of overall treatment experience, as recommended by IMMPACT guidelines. Satisfaction may also predict long-term adherence to treatment. This analysis presents a detailed exploration of factors influencing satisfaction in patients receiving SLF. Methods: Patient satisfaction data were pooled from two Phase III studies of SLF treatment for BTcP in opioid-tolerant patients. Both studies included a two-week titration phase and a longterm maintenance phase of ≤12 months. Patients rated satisfaction with current medication at baseline, and satisfaction with study treatment throughout SLF treatment.
Disclosure: None declared
F608 QUALITY OF LIFE IN PATIENTS WITH BREAKTHROUGH CANCER PAIN: RESULTS FROM TWO PHASE III STUDIES OF SUBLINGUAL FENTANYL J. Howell1 *, S. Dumble2 . 1 ProStrakan Group Ltd, Galashiels, 2 Quantics Consulting Ltd, Roslin, UK Background and Aims: Breakthrough cancer pain (BTcP) is a debilitating element of cancer pain. Improvement in physical and emotional functioning is a key therapeutic goal in pain management, and also a core outcome measure recommended by IMMPACT guidelines. This analysis examines factors influencing functioning during sublingual fentanyl (SLF) treatment for BTcP. Methods: Pooled data were collected from two Phase III studies of opioid-tolerant patients receiving SLF for BTcP. Both studies included a 2-week titration phase and a long-term maintenance phase of ≤12 months. Patients completed the Brief Pain Inventory (BPI) and Depression, Anxiety and Positive Outlook Scale (DAPOS) at screening and throughout SLF treatment. Subgroup analyses were performed for key demographic and treatment variables, corrected for multiple comparisons. Results: Of 270 enrolled patients, 151 were eligible for analysis. Baseline pain and functioning scores showed marked impairment
Fig. 1. Patient satisfaction at baseline and following successful titration.
Results: Overall, 270 patients enrolled in the studies. Of 250 patients who provided satisfaction data at baseline, approximately half were satisfied with pre-study medication, compared with >95% who were satisfied with study treatment following successful titration (Figure 1). There was no correlation between post-titration satisfaction and maintenance SLF dose, or time to successful titration. Patients who experienced severe pain
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POSTER SESSIONS / European Journal of Pain Supplements 5 (2011) 15–295
at baseline were more likely to be satisfied with treatment at later visits. Conclusions: This new analysis confirms that several factors may influence satisfaction. Titrated-dose SLF is associated with high levels of satisfaction, irrespective of time to titration and maintenance dosage, and may be particularly valuable for patients with severe baseline pain. This study was sponsored by ProStrakan Group Ltd. Disclosure: The study was sponsored by ProStrakan Group Ltd. JH is an employee of ProStrakan. Assistance with preparation of this abstract was provided by Acumen Healthcare Communications, supported by ProStrakan.
F610 NO SIGNIFICANT INFLUENCE OF AGE, GENDER OR RACE ON EFFICACY OF FENTANYL PECTIN NASAL SPRAY IN BREAKTHROUGH PAIN IN CANCER L. Torres1 *, M. Fallon2 , A. Burton3 . 1 University Hospital Puerta del Mar, Cadiz, Spain; 2 Western General Hospital, Edinburgh Cancer Centre, Edinburgh, UK; 3 University of Texas MD Anderson Cancer Center, Houston, TX, USA Background and Aims: Fentanyl pectin nasal spray (FPNS) has been shown to provide rapid pain relief that is also convenient and acceptable to patients with breakthrough pain in cancer (BTPc). To investigate whether age, gender or race affected the efficacy of FPNS, a post hoc analysis was conducted. Methods: The CP043 trial evaluated cancer patients experiencing one to four BTCP episodes/day while taking ≥60 mg/day oral morphine (or equivalent) for cancer pain. Following a titration phase, patients entered a double-blind phase, in which 10 BTPc episodes were treated with the effective FPNS dose (seven) or placebo (three). The effect of age was examined on the primary endpoint, summed pain intensity difference at 30 minutes; impact of gender and race were also evaluated. Results: Seventy-three patients were evaluable for SPID30 analysis. Fifteen (20.5%) were older than age 60, and 38 (52.1%) were male. After covariate analysis, no significant effect due to age category was seen (>60 years vs ≤60 years) (P = 0.6903). Betweentreatment differences were highly statistically significant for both males and females (P = 0.0017 and 0.0013, respectively). The race distribution was 53 Caucasian (72.6%), seven Black (9.6%), two Southeast Asian (2.7%) and 11 Other (15.1%), which were mostly Hispanic. No significant difference in response to FPNS was seen when comparing Caucasians to the other races. Conclusions: The above analysis suggests that neither age, gender nor race has a significant influence on the efficacy of FPNS, thus making its use applicable to a broad patient population. Disclosure: AB has received research grant support from Medtronic, Inc., and is on the speakers bureau for Elan, Inc.
F611 FENTANYL BUCCAL TABLETS FOR BREAKTHROUGH CANCER PAIN TREATMENT – RESULTS OF A NON-INTERVENTIONAL STUDY EVALUATING ITS ROUTINE USE IN GERMANY/AUSTRIA S. Lotfi1 , F.G. Mathers2 , D.T. Chang3 *. 1 Private Practice Specialised in Oncology, Pforzheim, 2 Private Practice for Pain Therapy and Anaesthesiology, Cologne, 3 Cephalon GmbH, Medical Department, Munich, Germany Background and Aims: Breakthrough cancer pain (BTcP) is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent cancer pain. A majority of cancer patients (51–95%) suffer from BTcP and studies have indicated that BTcP is associated with significant patient morbidity (decreased functioning, depression, distress, . . . ). Fentanyl buccal tablet (FBT) is a new opioid formulation that provides rapid-onset analgesia for the treatment of BTcP in patients already receiving opioid maintenance therapy. As part of a European risk management plan
a non-interventional study (NIS) was conducted in Germany and Austria to evaluate tolerability and efficacy of routine use of FBT. Methods: After a patient’s physician decided to treat BTcP with FBT, the patients’ pain management was systematically documented for up to 8 weeks. When the study’s final analyses are performed in May 2011, BTcP treatment of approximately 400 patients will be documented. Results: Interim analyses have already confirmed clinical trial data regarding efficacy and tolerability of FBT. Most patients reported sufficient pain relief within 10 minutes after application and FBT reduced the median pain intensity during BtcP episodes. More than 70% of the patients were satisfied with FBT treatment and rated the ease of FBT administration as “easy” or “very easy”. Adverse drug reactions were reported in less than 3% of all patients, and were non-serious and expected according to the European SmPC. Conclusions: Therefore, this NIS provided a representative crosssectional study of the routine use of FBT in Germany/Austria that confirmed efficacy and tolerability of FBT at managing BTcP. Disclosure: None declared
F612 LONG-TERM EFFICACY AND SAFETY OF THE FIXED COMBINATION OXYCODONE AND NALOXONE PROLONGED RELEASE (PR) IN PATIENTS WITH CHRONIC CANCER PAIN W. Leppert1 *, S.H. Ahmedzai2 , R. Uhl3 , W. Kremers3 , M. Hopp3 . 1 Department of Palliative Medicine, Poznan University of Medical Sciences, Poznan, Poland; 2 Academic Unit of Supportive Care, Dept. of Oncology, The University of Sheffield, Sheffield, UK; 3 European Medical Science, Mundipharma Research GmbH & Co, Limburg, Germany Introduction: Opioids are recommended for the treatment of severe pain. A common and distressing side effect of opioids is constipation due to their binding at peripheral opioid receptors in the gut. OXN PR is a prolonged-release fixed combination product consisting of oxycodone and naloxone in a 2:1 ratio, which has a comparable analgesic efficacy to oxycodone PR alone while in parallel counteracting opioid-induced constipation. Aim: To assess the long-term efficacy (analgesic and bowel function parameters) and safety (e.g. AEs, SOWS scores) of OXN PR. Methods: All Subjects entering the 24 weeks open-label Extension Phase (N = 128) of a corresponding Double-blind Phase study suffered from cancer pain and received open-label OXN PR up to a maximum daily dose of OXN120/60 mg PR. In the Double-blind Phase subjects received Oxycodone PR (OxyPR, N = 92) or OXN PR (N = 92). Results: The average pain score based on the BPI-SF remained stable during the Extension Phase (3.5 at start and 3.6 at end of study). The bowel function remained improved during the open-label Phase and the improvement was pronounced in subjects switching from OxyPR to OXN PR at the start of the Extension Phase (OXN2001S). Mean BFI value (SD) at the end of the Extension Phase was 38.90 (27.47). OXN PR was well tolerated during the Extension Phase. Mean SOWS scores (SD) were low [7.36 (6.24)]. Conclusions: OXN PR is well tolerated and efficacious for a chronic treatment of moderate to severe cancer pain. Acknowledgments: Supported by Mundipharma Research GmbH & Co. KG, Limburg (Lahn), Germany. Disclosure: Mundipharma Research GmbH & Co. KG is the sponsor of the respective Clinical Trial. The Authors Uhl, Kremers & Hopp are employees of Mundipharma Research GmbH & Co. KG. The authors Leppert & Ahmedzai participated in the Clinical Trial as Investigators.
Conclusions: We believe; the ultrasound guided 3–1 block and particularly FICB are parts of multimodal analgesic treatment in order to enable postoperative analgesia and these methods should be employed as a safe and efficient way. Disclosure: None declared
F607 A PERSONALIZED APPROACH TO POSTOPERATIVE PAIN IN DAY CARE SETTING: TWO YEAR FOLLOW-UP ON THE ANTWERP PERSONALIZED PAIN INITIATIVE G.H. Hans1,2 *, J. Leys3 , L. Sermeus1,2 , M. Vercauteren1,2 . 1 Multidisciplinary Pain Center (PCT), Antwerp University Hospital (UZA), 2 Department of Anesthesiology, 3 Department of Pharmacy, University Hospital of Antwerp (UZA), Edegem, Belgium Background and Aims: Chronification of pain after surgery is a recognised medical problem. However, little is known concerning the development of chronic pain after day care surgery. These patients quickly leave the hospital, receiving only minimal amounts of weak analgesics. To respond to this shortcoming, the Antwerp Personalised Pain Initiative was established. Methods: In a first phase of the project, incidence and intensity of postoperative pain was identified for diverse day care surgical procedures (total of 250 patients). It became evident that certain surgical procedures induce severe pain in up to 70% of patients, while other surgical procedures almost never induce moderate to severe pain. Additionally, an analysis of patient characteristics that negatively influence the risk of prolonged postoperative pain was carried out. Results: After identifying “high risk” surgical procedures and patient groups, an individualized approach to postoperative pain management was implemented. Based on personal characteristics of the patient and type of surgery that the patient is scheduled for, a patient-specific “risk-score” is composed. Based on this score an individualized pain management schedule is initiated. Upon discharge, the patient receives an “analgesic kit” (9 different kits were composed) containing a treatment for 3 up to 7 days (depending on patient’s total risk-score). Moreover, the patient has the possibility to invoke specialist advice via a dedicated telephone number. Conclusions: The progressive implementation of this project has resulted in a significant decrease of pain after day care surgery and highly increased patient satisfaction. Progress information over 2 yr period is provided.
171
across all subgroups. Moreover, younger patients (<50 years) experienced greater interference of pain with sleep, versus older patients (p = 0.001), and depression was greater in women versus men (p = 0.004). Improvements in several measures of pain and functioning were greater in patients who successfully titrated and were treated in the maintenance phase, compared to those who withdrew (p≤0.005 for pain relief, least pain and interference with sleep). Conclusions: This new analysis confirms that BTcP has detrimental impacts of quality of life, particularly in younger patients and women. The findings indicate that successful titration and continued therapy with an effective analgesic is important for improving pain and functioning. This study was sponsored by ProStrakan Group Ltd. Disclosure: The study was sponsored by ProStrakan Group Ltd. JH is an employee of ProStrakan. Assistance with preparation of this abstract was provided by Acumen Healthcare Communications, supported by ProStrakan.
F609 PATIENT SATISFACTION DURING TREATMENT WITH SUBLINGUAL FENTANYL FOR BREAKTHROUGH CANCER PAIN R. Rauck1 , M. Wallace2 , S. Nalamachu3 , D. Hassman4 , J. Howell5 *. 1 Carolinas Pain Institute Center for Clinical Research, Winston Salem, NC, 2 Center for Pain Medicine, University of California, San Diego, CA, 3 International Clinical Research Institute, Overland Park, KS, 4 Berlin Medical Associates, Berlin, NJ, USA; 5 ProStrakan Group Plc, Galashiels, UK Background and Aims: Sublingual fentanyl tablets (SLF, Abstral® ) have demonstrated efficacy for treatment of breakthrough cancer pain (BTcP) in opioid-tolerant patients. Evaluations of patients’ satisfaction with medication provide important measures of overall treatment experience, as recommended by IMMPACT guidelines. Satisfaction may also predict long-term adherence to treatment. This analysis presents a detailed exploration of factors influencing satisfaction in patients receiving SLF. Methods: Patient satisfaction data were pooled from two Phase III studies of SLF treatment for BTcP in opioid-tolerant patients. Both studies included a two-week titration phase and a longterm maintenance phase of ≤12 months. Patients rated satisfaction with current medication at baseline, and satisfaction with study treatment throughout SLF treatment.
Disclosure: None declared
F608 QUALITY OF LIFE IN PATIENTS WITH BREAKTHROUGH CANCER PAIN: RESULTS FROM TWO PHASE III STUDIES OF SUBLINGUAL FENTANYL J. Howell1 *, S. Dumble2 . 1 ProStrakan Group Ltd, Galashiels, 2 Quantics Consulting Ltd, Roslin, UK Background and Aims: Breakthrough cancer pain (BTcP) is a debilitating element of cancer pain. Improvement in physical and emotional functioning is a key therapeutic goal in pain management, and also a core outcome measure recommended by IMMPACT guidelines. This analysis examines factors influencing functioning during sublingual fentanyl (SLF) treatment for BTcP. Methods: Pooled data were collected from two Phase III studies of opioid-tolerant patients receiving SLF for BTcP. Both studies included a 2-week titration phase and a long-term maintenance phase of ≤12 months. Patients completed the Brief Pain Inventory (BPI) and Depression, Anxiety and Positive Outlook Scale (DAPOS) at screening and throughout SLF treatment. Subgroup analyses were performed for key demographic and treatment variables, corrected for multiple comparisons. Results: Of 270 enrolled patients, 151 were eligible for analysis. Baseline pain and functioning scores showed marked impairment
Fig. 1. Patient satisfaction at baseline and following successful titration.
Results: Overall, 270 patients enrolled in the studies. Of 250 patients who provided satisfaction data at baseline, approximately half were satisfied with pre-study medication, compared with >95% who were satisfied with study treatment following successful titration (Figure 1). There was no correlation between post-titration satisfaction and maintenance SLF dose, or time to successful titration. Patients who experienced severe pain
172
POSTER SESSIONS / European Journal of Pain Supplements 5 (2011) 15–295
at baseline were more likely to be satisfied with treatment at later visits. Conclusions: This new analysis confirms that several factors may influence satisfaction. Titrated-dose SLF is associated with high levels of satisfaction, irrespective of time to titration and maintenance dosage, and may be particularly valuable for patients with severe baseline pain. This study was sponsored by ProStrakan Group Ltd. Disclosure: The study was sponsored by ProStrakan Group Ltd. JH is an employee of ProStrakan. Assistance with preparation of this abstract was provided by Acumen Healthcare Communications, supported by ProStrakan.
F610 NO SIGNIFICANT INFLUENCE OF AGE, GENDER OR RACE ON EFFICACY OF FENTANYL PECTIN NASAL SPRAY IN BREAKTHROUGH PAIN IN CANCER L. Torres1 *, M. Fallon2 , A. Burton3 . 1 University Hospital Puerta del Mar, Cadiz, Spain; 2 Western General Hospital, Edinburgh Cancer Centre, Edinburgh, UK; 3 University of Texas MD Anderson Cancer Center, Houston, TX, USA Background and Aims: Fentanyl pectin nasal spray (FPNS) has been shown to provide rapid pain relief that is also convenient and acceptable to patients with breakthrough pain in cancer (BTPc). To investigate whether age, gender or race affected the efficacy of FPNS, a post hoc analysis was conducted. Methods: The CP043 trial evaluated cancer patients experiencing one to four BTCP episodes/day while taking ≥60 mg/day oral morphine (or equivalent) for cancer pain. Following a titration phase, patients entered a double-blind phase, in which 10 BTPc episodes were treated with the effective FPNS dose (seven) or placebo (three). The effect of age was examined on the primary endpoint, summed pain intensity difference at 30 minutes; impact of gender and race were also evaluated. Results: Seventy-three patients were evaluable for SPID30 analysis. Fifteen (20.5%) were older than age 60, and 38 (52.1%) were male. After covariate analysis, no significant effect due to age category was seen (>60 years vs ≤60 years) (P = 0.6903). Betweentreatment differences were highly statistically significant for both males and females (P = 0.0017 and 0.0013, respectively). The race distribution was 53 Caucasian (72.6%), seven Black (9.6%), two Southeast Asian (2.7%) and 11 Other (15.1%), which were mostly Hispanic. No significant difference in response to FPNS was seen when comparing Caucasians to the other races. Conclusions: The above analysis suggests that neither age, gender nor race has a significant influence on the efficacy of FPNS, thus making its use applicable to a broad patient population. Disclosure: AB has received research grant support from Medtronic, Inc., and is on the speakers bureau for Elan, Inc.
F611 FENTANYL BUCCAL TABLETS FOR BREAKTHROUGH CANCER PAIN TREATMENT – RESULTS OF A NON-INTERVENTIONAL STUDY EVALUATING ITS ROUTINE USE IN GERMANY/AUSTRIA S. Lotfi1 , F.G. Mathers2 , D.T. Chang3 *. 1 Private Practice Specialised in Oncology, Pforzheim, 2 Private Practice for Pain Therapy and Anaesthesiology, Cologne, 3 Cephalon GmbH, Medical Department, Munich, Germany Background and Aims: Breakthrough cancer pain (BTcP) is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent cancer pain. A majority of cancer patients (51–95%) suffer from BTcP and studies have indicated that BTcP is associated with significant patient morbidity (decreased functioning, depression, distress, . . . ). Fentanyl buccal tablet (FBT) is a new opioid formulation that provides rapid-onset analgesia for the treatment of BTcP in patients already receiving opioid maintenance therapy. As part of a European risk management plan
a non-interventional study (NIS) was conducted in Germany and Austria to evaluate tolerability and efficacy of routine use of FBT. Methods: After a patient’s physician decided to treat BTcP with FBT, the patients’ pain management was systematically documented for up to 8 weeks. When the study’s final analyses are performed in May 2011, BTcP treatment of approximately 400 patients will be documented. Results: Interim analyses have already confirmed clinical trial data regarding efficacy and tolerability of FBT. Most patients reported sufficient pain relief within 10 minutes after application and FBT reduced the median pain intensity during BtcP episodes. More than 70% of the patients were satisfied with FBT treatment and rated the ease of FBT administration as “easy” or “very easy”. Adverse drug reactions were reported in less than 3% of all patients, and were non-serious and expected according to the European SmPC. Conclusions: Therefore, this NIS provided a representative crosssectional study of the routine use of FBT in Germany/Austria that confirmed efficacy and tolerability of FBT at managing BTcP. Disclosure: None declared
F612 LONG-TERM EFFICACY AND SAFETY OF THE FIXED COMBINATION OXYCODONE AND NALOXONE PROLONGED RELEASE (PR) IN PATIENTS WITH CHRONIC CANCER PAIN W. Leppert1 *, S.H. Ahmedzai2 , R. Uhl3 , W. Kremers3 , M. Hopp3 . 1 Department of Palliative Medicine, Poznan University of Medical Sciences, Poznan, Poland; 2 Academic Unit of Supportive Care, Dept. of Oncology, The University of Sheffield, Sheffield, UK; 3 European Medical Science, Mundipharma Research GmbH & Co, Limburg, Germany Introduction: Opioids are recommended for the treatment of severe pain. A common and distressing side effect of opioids is constipation due to their binding at peripheral opioid receptors in the gut. OXN PR is a prolonged-release fixed combination product consisting of oxycodone and naloxone in a 2:1 ratio, which has a comparable analgesic efficacy to oxycodone PR alone while in parallel counteracting opioid-induced constipation. Aim: To assess the long-term efficacy (analgesic and bowel function parameters) and safety (e.g. AEs, SOWS scores) of OXN PR. Methods: All Subjects entering the 24 weeks open-label Extension Phase (N = 128) of a corresponding Double-blind Phase study suffered from cancer pain and received open-label OXN PR up to a maximum daily dose of OXN120/60 mg PR. In the Double-blind Phase subjects received Oxycodone PR (OxyPR, N = 92) or OXN PR (N = 92). Results: The average pain score based on the BPI-SF remained stable during the Extension Phase (3.5 at start and 3.6 at end of study). The bowel function remained improved during the open-label Phase and the improvement was pronounced in subjects switching from OxyPR to OXN PR at the start of the Extension Phase (OXN2001S). Mean BFI value (SD) at the end of the Extension Phase was 38.90 (27.47). OXN PR was well tolerated during the Extension Phase. Mean SOWS scores (SD) were low [7.36 (6.24)]. Conclusions: OXN PR is well tolerated and efficacious for a chronic treatment of moderate to severe cancer pain. Acknowledgments: Supported by Mundipharma Research GmbH & Co. KG, Limburg (Lahn), Germany. Disclosure: Mundipharma Research GmbH & Co. KG is the sponsor of the respective Clinical Trial. The Authors Uhl, Kremers & Hopp are employees of Mundipharma Research GmbH & Co. KG. The authors Leppert & Ahmedzai participated in the Clinical Trial as Investigators.