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Stakeholder Insight: HIV Related Neuropathic Pain - Useful Niche for Peripheral Companies


Description: Fueled by the growing interest in neuropathic pain but keen to avoid competition with larger players, small companies recognize the commercial opportunity of the HIV-related neuropathic pain (HIVNP) market. Not only does HIVNP offer a well-served patient base and good awareness, it is also a useful stepping-stone to larger more prevalent neuropathic pain types and thus greater commercial gains. Scope of Report: Quantitative treatment data from over 171 physicians from the US, France, Germany, Italy, and the UK Analysis of epidemiology, assessment and referral patterns, first- to third-line treatments, and unmet market needs Discussion of the R&D drug pipeline for HIVNP, with analysis of NeurogesX’s patch analgesic NGX-4010 and Savient’s nerve growth stimulator Prosaptide Coverage of the hot topics including education of HIV specialists, reducing pill burden, and the potential of pathogenesis-based treatments Report Highlights: In countries such as the US and the UK there is a strong therapeutic relationship between HIVNP patients and HIV specialists. Although patients tend to be well served and treatment initiated reasonably early, there is still a need to educate HIV physicians on HIVNP management. The tricyclic antidepressant amitriptyline is a popular treatment of neuropathic pain across the 7 markets, although its side effects are intolerable to many HIVNP patients. The newer serotonin and noradrenaline reuptake inhibitor class of antidepressants, however, appears to offer a cleaner side effect profile with equivalent analgesic ability. In the long-term, the future HIVNP market will see the launch of pathogenesis-based therapies, such as nerve growth factor agonists. However, while the search for effective neurotrophic compounds that can halt or ideally reverse nerve damage causing HIVNP continues, analgesics will remain an important part of pain management. Reasons to Purchase: Forecast product sales by understanding key aspects of HIVNP epidemiology, referral, diagnosis, treatment, and unmet needs Improve pain product positioning strategies by realizing the commercial advantages offered by the HIVNP niche Understand how the HIVNP market provides an opening to more profitable neuropathic pain indications in the US


Contents: CHAPTER 1 Executive summary 3 1.1 Scope of the Analysis 3 1.2 Insight into HIV-related neuropathic pain 3 Neuropathic pain affects over 480,000 people with HIV across the seven major pharmaceutical markets. In countries such as the US and the UK there is a strong therapeutic relationship between HIVNP patients and HIV specialists. Although patients tend to be well served and treatment initiated reasonably early, there is still a need to educate HIV physicians on HIVNP management. 4 The tricyclic antidepressant amitriptyline is a popular treatment of neuropathic pain across the seven markets, although its side effects are intolerable to many HIVNP patients. The newer SNRI class of antidepressants, however, appears to offer a cleaner side effect profile with equivalent analgesic ability. A key advantage of these drugs is that, given the high prevalence of comorbid depression among HIV sufferers, they possess a dual therapeutic action thus reducing the all important pill burden. 5 In the long-term, the future HIVNP market will see the launch of pathogenesis-based therapies, such as nerve growth factor agonists. However, while the search for effective neurotrophic compounds that can halt or ideally reverse nerve damage causing HIVNP continues, analgesics will remain an important part of pain management. 6 Summary 7 1.3 HIV-related neuropathic pain insight: methodology 8 CHAPTER 2 Introduction 16 CHAPTER 3 Patient Potential 17 3.1 Definition and classification of HIV related neuropathy 17 3.2 Epidemiology across the seven major markets 18 Prevalence 18 Breakdown by severity 19 CHAPTER 4 Assessment and treatment 22 4.1 Referral patterns 22 Overview 22 US 23 France 24 Germany 24 Italy 25 UK 25 4.2 Importance of therapeutic endpoints on prescribing decisions 27 Overview 27 US 28 France 28 Germany 29 Italy 30 UK 30 4.3 Pharmacotherapy 31 Introduction 31 4.4 Treatment of HIV-related neuropathic pain in five major markets 32 Profiles of commonly used drugs 32 Gabapentin 33 Lidocaine patch 35 Amitriptyline 35 Lamotrigine 37 US 38 First-line therapy 39 Second-line therapy 40 Third-line therapy 41 France 41 First-line therapy 43 Second-line therapy 43 Third-line therapy 44 Germany 45 First-line therapy 46 Second-line therapy 47 Third-line therapy 48 Italy 49 First-line therapy 50 Second-line therapy 50 Third-line therapy 52 UK 52 First-line therapy 54 Second-line therapy 55 Third-line therapy 56 4.5 R&D drugs 57 Pipeline overview 57 NGX-4010 58 Prosaptide 59 4.6 Unmet needs 59 Improved pain relief and reduced pill burden 59 Improved diagnosis and early intervention 60 Improved HIVNP drug efficacy measures 60 Minimal drug interactions 61 CHAPTER 5 Appendix A 62 5.1 Bibliography 62 References 62 Websites 65 5.2 Contributing experts 65 Professor John D Loeser MD 65 Professor Kazuo Hanaokam MD 65 Professor Cesare Fieschi MD 65 Professor Henry J McQuay MD 66 Professor Praveen Anand MD 66 Professor Shuji Dohi MD 66 Professor Andreas Straube MD 66 Professor Giorgio Sandrini MD 66 Assistant Professor Brian D Loftus MD 66 Associate Professor Barth L Wilsey MD 66 Dr Gockel MD 66 Dr Gary J McCleane MD 67 Dr Philippe Poulain MD 67 Dr Ricardo Ruiz-Lopez MD 67 Dr Charles H Ripp MD 67 Dr David Bowsher MD 67 Dr Justin C Riutta MD 67 Dr Derek Enlander MD 67 Dr Delong MD 67 Dr Ducloux MD 68 Professor Vignon MD 68 Professor Lauren Shaiova MD 68 Professor Donald I Abrams MD 68 Dr Nicola E Mackie MD 68 5.3 Physician research methodology 68 Introduction 68 Our research partners 70 Research objectives 71 Questionnaire development 73 Research methodology 74 Data processing 76 Quality control 76 5.4 Neuropathic Pain Insight Questionnaire 77 CHAPTER 6 Appendix B 84 Research and analysis methodologies 85 About the CNS analysis team 86 Key therapy team members 88 Lynda Lynch, Director CNS 88 David Abramson, Therapeutic Lead Consultant 89 About the Author 89 Ben Greener, Senior CNS Analyst 89




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