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Abstract
Objective:
The effects of combined oxycodone/naloxone prolonged release tablets (OXN PR) were investigated in patients with moderate-to-severe chronic cancer-related or non-cancer pain. All patients had opioid-induced constipation (OIC) which persisted despite substantial laxative therapy.
Research design and methods:
This pooled analysis included 75 patients with OIC at study entry that was refractory to at least two laxatives with different modes of action. Patients completed randomized, double-blind treatment with OXN PR 20–120 mg/day for either 12 weeks (OXN 9001: non-cancer pain study) or 4 weeks (OXN 2001: cancer-related pain study). Analgesia and bowel function were assessed using the Brief Pain Inventory Short Form and Bowel Function Index (BFI), respectively. Use of laxative medication and safety were assessed throughout the studies.
Clinical trial registration:
ClinicalTrials.gov identifier: NCT00513656.
EudraCT 2005-002398-57, EudraCT 2005-003510-15.
Results:
Statistically and clinically significant improvements in bowel function were observed following double-blind treatment with OXN PR. Mean (SD) reduction in BFI score was 21.2 (28.8) and comparable in patients with cancer-related (19.0 [28.9]) and non-cancer pain (23.3.[29.0]; P ≤ 0.0002). Furthermore, the proportion of patients with a BFI score within normal range (≤28.8) increased from 9.5% at screening to 43.1% at Day 15 of OXN PR. While all patients used ≥2 laxatives of different classes at screening, during study treatment 36% stopped using laxatives (P < 0.001). OXN PR provided effective analgesia, evidenced by stable pain scores during study treatment, and there were no unanticipated adverse events.
Conclusions:
OXN PR significantly improved bowel function and reduced the use of laxatives in patients with OIC, previously unresponsive to at least two different classes of laxatives. OXN also provided effective analgesia for patients with moderate-to-severe cancer-related pain and non-cancer-related pain.
Transparency
Declaration of funding
The study was sponsored by Mundipharma Pharmaceuticals BV. Statistical support was funded by Mundipharma Pharmaceuticals BV, and medical writing assistance was funded by Mundipharma Research GmbH & Co. KG.
Declaration of financial or other relationships
G.K. and Y.V.M. have disclosed that they are employees of Mundipharma Pharmaceuticals BV. M.W. and J.D.A. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. K.S. has disclosed that she has received fees for consultancy and speakers’ bureau, and sponsorship from Medtronic Ltd, Napp Pharmaceuticals Group, Janssen-Cilag Ltd, Pfizer, Schwartz Pharma Ltd, St Jude Medical, Eisai, Cephalon, G & W Laboratories Inc., Reckitt and Benckiser, Stryker Corporation, Arthrocare Corporation, and Grünenthal. E.A.L. has disclosed that he has received sponsorship from Grünenthal, TEVA and Optimal Medical Therapies, and consultancy fees from Grünenthal, TEVA and Mundipharma Pharmaceuticals.
CMRO peer reviewers on this manuscript have received an honorarium from CMRO for their review work. Peer reviewers 1 and 2 have no relevant financial or other relationships to disclose. Peer reviewer 3 has been a member of the Mundipharma speakers’ bureau.
Acknowledgments
Medical writing support was provided by Siân Marshall PhD of Siantifix Ltd, Cambridgeshire, UK. Statistical support was provided by Ir. C.A.H. Mudde, of Clinquest Services B.V., s-Hertogenbosch, The Netherlands.
Notes
*Copyright for the Bowel Function Index is owned by Mundipharma GmbH, Switzerland, 2002; the BFI is subject of European Patent Application Publication No. EP 1,860,988 and corresponding patents and applications in other countries