Printer Friendly Printed from http://www.researchandmarkets.com/reports/219058 Stakeholder Insight: Neuropathic Low Back Pain - Off-label Revenue Despite Diagnostic Challenge Description: Introduction Despite millions of patients worldwide, not one neuropathic pain drug company is prioritizing the neuropathic low back pain (NLBP) market. The problem is simply that this patient group is difficult to define in clinical practice. Once diagnosis is made, however, physicians commonly prescribe recognized neuropathic pain drugs, thus NLBP offers a significant source of off-label drug sales in the US. Scope - Quantitative treatment data from over 384 physicians from the US, Japan, France, Germany, Italy, Spain, and the UK - Analysis of epidemiology, assessment and referral patterns, and first- to third-line treatments - Discussion of the market need for more evidence-based treatments, improved diagnosis and identification of treatment responders - Coverage of the hot topics including the use of opioids, the upcoming launch of pregabalin Highlights - Neuropathic low back pain affects an estimated 5.6 million people in the US alone. However, this type of back pain is rarely diagnosed and is poorly treated in the primary care setting. As such, there is strong need to educate physicians, especially PCPs, about the difference between the types of low back pain. - There is little consensus as to best treatment practice between countries and even between physician types, which is compounded by the heterogeneity of patients and a dearth of randomized controlled trial data. A company can grow its share of the market by providing clear, convincing scientific data as either monotherapy or combination. - The future market is not entirely the reserve of generic companies and Pfizer. A significant commercial opportunity exists for medical device companies, although the biggest challenge is to change the physician perception that interventional treatment of NLBP is a modestly effective last resort. Reasons to Purchase - Forecast product sales by understanding key aspects of NLBP epidemiology, referral, diagnosis, treatment, and unmet needs - Improve pain product positioning strategies by identifying the commercial opportunities offered by the NLBP niche - Understand why this untapped market warrants pharmaceutical industry interest Contents: TABLE OF CONTENTS About the CNS pharmaceutical analysis team 2 CHAPTER 1 Executive summary 3 1.1 Scope of the Analysis 3 1.2 Insight into neuropathic low back pain 3 Neuropathic low back pain affects an estimated 5.6 million people in the US alone. However, with insufficient diagnostic criteria coupled with no approved treatments, this type of back pain is rarely diagnosed and thus poorly treated in the primary care setting. Misdiagnosis is also a significant problem as it can hinder treatment outcome and can increase the rate of recurrence. As such, there is strong need to educate physicians, especially PCPs, about the difference between the different types of low back pain. 4 The most popular treatments of NLBP across the seven markets include gabapentin, amitriptyline and NSAIDs, which are often used in combination. However, there is little consensus as to best treatment practice between countries and even between physician types, which is compounded by the heterogeneity of patients and a dearth of randomized controlled trial data. 6 For at least the next five years generic gabapentin, NSAIDs, opioids, and antidepressants will continue to be the mainstay of NLBP management. Pfizer's successor to gabapentin, pregabalin will also play an important role in the market. But the market is not entirely the reserve of generic companies and Pfizer. A significant commercial opportunity exists for medical device companies, although the biggest challenge is to change the physician perception that interventional treatment of NLBP is a modestly effective 'last resort'. 7 1.3 Neuropathic Low Back Pain Insight: methodology 9 CHAPTER 2 Introduction 17 CHAPTER 3 Patient Potential 18 3.1 Definition of neuropathic low back pain 18 3.2 Etiology 18 Peripheral injury to non-neural tissue 18 Peripheral injury to neural tissue 19 3.3 Epidemiology 20 NLBP population across the seven major markets 20 Prevalence of low back pain in the US 20 Prevalence of low back pain in Germany 21 Prevalence of low back pain in Spain 22 Prevalence of low back pain in the UK 23 Frequency of neuropathic low back pain 25 Breakdown of pain severity by physician type 26 CHAPTER 4 Assessment and treatment 30 4.1 Referral patterns 30 Overview 30 US 31 Japan 32 France 32 Germany 33 Italy 34 Spain 34 UK 35 4.2 Importance of therapeutic endpoints on prescribing decisions 36 Overview 36 US 38 Japan 38 France 39 Germany 40 Italy 41 Spain 41 UK 42 4.3 Pharmacotherapy 43 Introduction 43 Antidepressants 44 Anticonvulsants 45 Opioids 46 NSAIDs 48 4.4 Treatment of neuropathic low back pain across the seven major markets 50 Overview of commonly used drugs 50 Summary of NLBP treatment 50 Gabapentin 51 Amitriptyline 53 Tramadol 54 US 55 First-line therapy 57 Second-line therapy 57 Third-line therapy 59 Japan 60 First-line therapy 61 Second-line therapy 62 Third-line therapy 62 France 64 First-line therapy 64 Second-line therapy 66 Third-line therapy 67 Germany 68 First-line therapy 69 Second-line therapy 69 Third-line therapy 70 Italy 71 First-line therapy 72 Second-line therapy 73 Third-line therapy 74 Spain 74 First-line therapy 75 Second-line therapy 76 Third-line therapy 77 UK 78 First-line therapy 79 Second-line therapy 80 Third-line therapy 81 CHAPTER 5 LIDOCAINE Patch 81 5.1 The commercial potential of implantable systems 82 Introduction 82 Medtronic's Synergy neurostimulation system for NLBP 82 Intrathecal pumps 83 A niche market 84 5.2 Unmet needs 85 More evidence based treatments 86 Improved diagnosis and identifying treatment responders 87 CHAPTER 6 Appendix A 89 6.1 Bibliography 89 References 89 Websites 94 6.2 Contributing experts 94 Professor John D Loeser MD 94 Professor Kazuo Hanaokam MD 94 Professor Cesare Fieschi MD 94 Professor Henry J McQuay MD 94 Professor Praveen Anand MD 94 Professor Shuji Dohi MD 95 Professor Andreas Straube MD 95 Professor Giorgio Sandrini MD 95 Assistant Professor Brian D Loftus MD 95 Associate Professor Barth L Wilsey MD 95 Dr Gockel MD 95 Dr Gary J McCleane MD 95 Dr Philippe Poulain MD 95 Dr Ricardo Ruiz-Lopez MD 96 Dr Charles H Ripp MD 96 Dr David Bowsher MD 96 Dr Justin C Riutta MD 96 Dr Derek Enlander MD 96 Dr Delong MD 96 Dr Ducloux MD 96 Professor Vignon MD 96 Professor Lauren Shaiova MD 97 Professor Donald I Abrams MD 97 Dr Nicola E Mackie MD 97 6.3 Physician research methodology 97 Introduction 97 Our research partners 99 Research objectives 100 Questionnaire development 102 Research methodology 102 Data processing 105 Quality control 105 6.4 Neuropathic Pain Insight Questionnaire 105 CHAPTER 7 Appendix B 112 About the CNS analysis team 114 Key therapy team members 116 Lynda Lynch, Director CNS 116 David Abramson, Therapeutic Lead Consultant 117 About the Author 117 Ben Greener, Senior CNS Analyst. 117 Disclaimer 119 Ordering: Order Online - visit http://www.researchandmarkets.com/reports/219058 Order by Fax - using the order form below Order By Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8, Ireland. 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