Grünenthal GmbH

Improved pain relief for patients with severe chronic low back pain - results of a new study show 37%* more pain relief with Palexia® (tapentadol PR) compared to oxycodone/naloxone PR

Aachen (ots) - EMBARGO: This information is for European healthcare professionals only. Not intended for UK audience.

Low back pain is one of the most common chronic pain conditions. Studies have shown that up to 85% of people worldwide will suffer from back pain during their lives.(1) A high percentage of severe chronic low back pain cases has a neuropathic pain component, which may make pain management more difficult.(2,3) For the approximately 80% of severe chronic low back pain patients for whom such a neuropathic pain component cannot be excluded, adequate pain management requires that both the nociceptive and neuropathic components of their pain should be addressed.(4)

Results of a recent randomized, open-label, phase 3b/4 study provided evidence for the superior effectiveness of tapentadol prolonged release (PR), an innovative centrally acting analgesic with 2 mechanisms of action, compared with the fixed-dose combination product oxycodone/naloxone PR, for the treatment of severe chronic low back pain with a neuropathic pain component.(5,6)

Tapentadol PR provides effective pain relief and improved control of neuropathic pain symptoms compared to oxycodone/naloxone PR

Achieving adequate analgesia is challenging for patients with chronic pain, especially since a high percentage of cases a neuropathic component cannot be excluded.4 Based on these trial results, tapentadol PR may be considered a first-line option for managing severe chronic low back pain with a neuropathic component.(6) The study showed better outcomes in the tapentadol group than in the oxycodone/naloxone PR group for effectiveness, quality of life, and gastrointestinal (GI) tolerability as well as in neuropathic symptoms.

The results of this study show that tapentadol PR provided superior analgesic effectiveness to oxycodone/naloxone PR.(6) In the change in pain intensity from baseline to final evaluation the tapentadol PR treated group showed 37%* greater reduction of pain intensity when compared to that of the oxycodone/naloxone PR group.(6)

Patients who received tapentadol PR also experienced significantly greater reductions in neuropathic pain-related symptoms over the course of treatment and a clear reduction of pain attacks.(6)

Tapentadol PR offers improved gastrointestinal tolerability

Opioid analgesics are commonly used for the management of chronic low back pain.(7) However, the use of opioids for chronic pain management is often hindered by the occurrence of side effects, particularly GI side effects, that may lead patients to discontinue treatment, resulting in disruption of pain relief.(8-11)

In this study, tapentadol PR was shown to have a favorable GI tolerability profile and was associated with an approximately 40%** lower incidence of constipation and an approximately 53% lower incidence of vomiting than oxycodone/naloxone PR.(12)

Superior pain control and improved control of neuropathic pain symptoms when compared to oxycodone/naloxone PR, as well as the favorable GI tolerability profile associated with tapentadol PR may lead to improved adherence to treatment. In the phase 3b/4 study, 77%*** more patients stayed on tapentadol PR treatment compared with oxycodone/naloxone PR treatment.(12)

Tapentadol PR treatment results in improved patient quality of life

Inadequately managed chronic pain has a substantial negative impact on a patient's mental health, function, and overall quality of life.(13)

This study showed that tapentadol PR was associated with significant improvements in measures of health-related quality of life and function compared with oxycodone/naloxone PR. These improvements were observed across different validated measures, including assessments of physical functioning, bodily pain, vitality, and social functioning (based on SF-12). At the end of study treatment, approximately 79% of patients who received tapentadol PR rated their overall health status as improved (based on PGIC).(14)

In summary, results of this recent phase 3b/4 study indicate that tapentadol PR may be a good first-line option for managing severe chronic low back pain when a neuropathic pain component cannot be excluded, offering improved pain relief and GI tolerability, as well as better control of neuropathic pain-related symptoms, compared with oxycodone/naloxone PR.

About tapentadol

Currently, tapentadol prolonged-release tablets, indicated for the management of severe chronic pain in adults that can only be adequately managed with opioid analgesics, and tapentadol immediate-release tablets for the management of moderate to severe acute pain in adults that can only be adequately managed with opioid analgesics, are both licensed in 25 European countries.

Tapentadol Co-Development

Grünenthal discovered and developed tapentadol. Grünenthal holds the rights to major parts of its home market Europe and Latin America. In Australia tapentadol will be co-promoted with a local partner. Grünenthal licensed exclusive rights to tapentadol to Janssen Pharmaceuticals, Inc. and Janssen Research & Development, L.L.C. for the United States, Canada and Japan, and other countries around the world where Grünenthal has no commercial organization. Grünenthal and Janssen Research & Development, L.L.C. have conducted the phase IIb and III development programs for tapentadol for acute and chronic pain conditions.

About Grünenthal

The Grünenthal Group is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. Building on its unique position in pain treatment, its objective is to become the most patient-centric company in the field of pain and thus to be a leader in therapy innovation.

Grünenthal is one of the last five remaining research-oriented pharmaceutical companies with headquarters in Germany which sustainably invests in research and development. Research and development costs amounted to about 27 percent of revenues in 2013. Grünenthal?s research and development strategy concentrates on selected fields of therapy and state-of-the-art technologies. We are intensely focused on discovering new ways to treat pain better and more effectively, with fewer side-effects than current therapies.

Altogether, the Grünenthal Group has affiliates in 25 countries worldwide. Grünenthal products are sold in more than 155 countries and approx. 5,500 employees are working for the Grünenthal Group worldwide. In 2013, Grünenthal achieved revenues of EUR 901 mn.

More information: www.grunenthal.com

References

*NRS-3 LS mean (SE) change from baseline to final evaluation: ?2.7 (0.26); for oxycodone/naloxone PR and ?3.7 (0.25); for Tapentadol PR, per protocol set, LOCF

P = 0.003 (confirmatory analysis; superiority; tapentadol PR vs oxycodone/naloxone PR). Percent difference between tapentadol PR and oxycodone/naloxone PR, using oxycodone/naloxone PR as the base (denominator). 37% more pain reduction was observed from baseline to final evaluation with tapentadol PR than with oxycodone/naloxone PR.

**Incidence of constipation during the overall treatment period (safety set): 25.8 % with oxycodone/naloxone PR vs. 15.4% with tapentadol PR, P = 0.045 tapentadol PR vs oxycodone/naloxone PR. Percent difference between tapentadol PR and oxycodone/naloxone PR, using oxycodone/naloxone PR as the base (denominator).

***Percentage of patients who completed study treatment (safety set): 37.5% with Oxycodone/naloxone PR and 66.2% with Tap PR; 76.53% Percent difference between tapentadol PR and oxycodone/naloxone PR, using oxycodone/naloxone PR as the base (denominator). i.e. Approximately 77% more patients stayed on tapentadol PR compared with oxycodone/naloxone PR (77% more adherence).

1. The Bone & Joint Decade Department of Orthopedics: European Action Towards Better Musculoskeletal Health: A Public Health Strategy to Reduce the Burden of Musculoskeletal Conditions. [cited 2010 September 9]. Available from: http://ec.europa.eu/health/ph_projects/2000/promotion/fp_promotion_2000_frep_15_en.pdf.

2. Fishbain DA et al. What is the evidence that neuropathic pain is present in chronic low back pain and soft tissue syndromes? An evidence-based structured review. Pain Med. 2014;15(1):4-15.

3. Baron R et al. Neuropathic pain: diagnosis, pathophysiological mechanisms, and treatment. Lancet Neurol. 2010;9(8):807-819.

4. Freynhagen R et al. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin. 2006;22(10):1911-1920.

5. Tzschentke TM et al. Tapentadol hydrochloride: a next-generation, centrally acting analgesic with two mechanisms of action in a single molecule. Drugs Today (Barc). 2009;45(7):483-496.

6. Baron R et al. Effectiveness of tapentadol prolonged release (PR) versus oxycodone/naloxone PR for severe chronic low back pain with a neuropathic pain component. Poster presented at PAIN Week September 2014, Las Vegas, USA.

7. Altman RD et al. Opioid therapy for osteoarthritis and chronic low back pain. Postgrad Med. 2010;122(6):87-97.

8. Porreca F et al. Nausea and vomiting side effects with opioid analgesics during treatment of chronic pain: mechanisms, implications, and management options. Pain Med. 2009;10(4):654-662.

9. Benyamin R et al. Opioid complications and side effects. Pain Physician. 2008;11(2 suppl):S105-S120.

10. Panchal SJ et al. Opioid-induced bowel dysfunction: prevalence, pathophysiology and burden. Int J Clin Pract. 2007;61(7):1181-1187.

11. Kalso E et al. Opioids in chronic non-cancer pain: systematic review of efficacy and safety. Pain. 2004;112(3):372-380.

12. Binder A et al. Safety and tolerability of tapentadol prolonged release (PR) versus oxycodone/naloxone PR for severe chronic low back pain with a neuropathic pain component. Poster presented at PAIN Week September 2014, Las Vegas, USA.

13. McCarberg BH et al. The impact of pain on quality of life and the unmet needs of pain management: results from pain sufferers and physicians participating in an Internet survey. Am J Ther. 2008;15(4):312-320.

14. Schwittay A et al. Effects of tapentadol prolonged release (PR) versus oxycodone/naloxone PR on quality of life and function measures in patients with severe chronic low back pain with a neuropathic pain component. Poster presented at PAIN Week September 2014, Las Vegas, USA.

Contact:

Jeanette Hübsch, Head of Brand Communication Palexia, 
Grünenthal Europe & Australia
Phone: +49 241-569-1487,
Fax: +49 241-569-3474
jeanette.huebsch@grunenthal.com


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