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OXYCONTIN, OXYNORM, OXYNORMORO (oxycodone), opioid
Reason for request
Substantial clinical benefit in certain kinds of severe and/or intractable pain in osteoarthritis of the knee or hip and in chronic lumbar pain
Insufficient clinical benefit in the other types of chronic, intense and/or in tractable, non-cancer-related and non-neuropathic pain
- Proprietary medicinal products containing oxycodone (OXYCONTIN, OXYNORM, OXYNORMORO) have Marketing Authorisation in the treatment of severe pain that can only be treated adequately with strong opioid analgesics, in particular in the case of cancer-related pain. OXYCONTIN is administered every 12 hours as a disease-modifying treatment, while OXYNORM and OXYNORMORO are administered every 4 to 6 hours for treating episodes of paroxysmal pain.
- Despite the lack of clinical efficacy and safety data of methodologically acceptable quality, many French and foreign guidelines recommend – under certain conditions and restrictions and within a strict framework – giving preference to the oral route, the use of strong opioids in cases of chronic rheumatism pain (disabling rheumatoid arthritis of the hip or knee and lumbar pain).
- Their clinical benefit, however, is insufficient in the other types of chronic non-cancer-related and non-neuropathic pain.
Clinical Benefit
| Substantial |
Substantial in the management of intense and/or intractable pain occurring in the context of osteoarthritis of the knee or hip and chronic lumbar pain, as a last-resort treatment, at a stage where surgery is planned or in patients who are not candidates (due to refusal or contraindication) for prosthetic joint replacement surgery (in osteoarthritis of the hip or knee), and for the shortest duration possible due to the risk of serious adverse effects and the absence of long-term efficacy and safety data. Oxycodone-based medicinal products should be used as little as possible, after failure of other pharmacological and non-pharmacological treatments (including physiotherapy) recommended in these indications. |
| Insufficient |
Insufficient in severe and/or intractable pain occurring in any other chronic non‑cancer and non-neuropathic pain context, particularly chronic inflammatory rheumatic diseases, primarily consisting of rheumatoid arthritis and spondyloarthritis. |
