Neuropathic pain (NP) is defined as a disorder of the sensorimotor system and is distinctly different from nociceptive pain, which is a consequence of trauma, injury, or inflammation. The main difference between neuropathic and nociceptive pain is the absence of a continuous nociceptive input in neuropathic pain. Although the term neuropathic pain is used to describe a wide range of pain syndromes with varying etiologies, this report focuses on 3 distinct forms of NP: Painful diabetic neuropathy, Postherpetic neuralgia and trigeminal neuralgia. The main classes of drugs used to treat these three neuropathic pain indications include anticonvulsants, antidepressants, opioids and topical treatments. However, despite the availability of multiple pain medications only 50% of patients respond to any given drug and there are numerous the side effects associated particularly with systemically administered drugs, that reduce their tolerability. New treatments will target some key unmet needs in terms of efficacy and tolerability, but opportunities will remain for drugs that can more reliably eradicated NP in targeted patient populations, as well as offering an improved safety profile.

BioDelivery Sciences International (BDSI) is currently planning Phase III clinical trials of a Topical Clonidine gel (0.1% clonidine hydrochloride) for the treatment of PDN, after the company entered into a worldwide licensing agreement with Arcion Therapeutics for clonidine in March 2013. Arcion had previously completed Phase II trials of the drug in PDN in December 2009, the results of which showed that it was effective in reducing pain associated with PDN, particularly in subjects with evidence of preserved nociceptors. In September 2010, Arcion Therapeutics received a Fast-Track designation from the FDA for the topical clonidine gel for the treatment of pain associated with PDN.

Scope

• Overview of Neuropathic pain, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
• Detailed information on Topical Clonidine including product description, safety and efficacy profiles as well as a SWOT analysis.
• Sales forecast for Topical Clonidine for the top six countries from 2012 to 2022.
• Sales information covered for the US, France, Germany, Italy, Spain and the UK.

Reasons to buy

• Understand and capitalize by identifying products that are most likely to ensure a robust return
• Stay ahead of the competition by understanding the changing competitive landscape for Neuropathic pain
• Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
• Make more informed business decisions from insightful and in-depth analysis of Topical Clonidine performance
• Obtain sales forecast for Topical Clonidine from 2012-2022 in the top six countries (the US, France, Germany, Italy, Spain and the UK).

Table of Contents

1 Table of Contents 6
1.1 List of Tables 9
1.2 List of Figures 10

2 Introduction 11
2.1 Catalyst 11
2.2 Related Reports 11

3 Disease Overview 13
3.1 Clinical Manifestations of Neuropathic Pain - Signs and Symptoms 15
3.1.1 Painful Diabetic Neuropathy 17
3.1.2 Postherpetic Neuralgia 18
3.1.3 Trigeminal Neuralgia 18
3.2 Etiology and Pathophysiology 19
3.2.1 Etiology 20
3.2.2 Pathophysiology 21

4 Disease Management 29
4.1 Diagnosis and Treatment Overview 29
4.1.1 Diagnosis 29
4.1.2 Treatment Overview and Guidelines 36

5 Competitive Assessment 46
5.1 Overview 46

6 Unmet Need and Opportunity 51
6.1 Overview 51
6.2 Physician Knowledge or Awareness 52
6.2.1 Unmet Need 52
6.2.2 Gap Analysis 53
6.2.3 Opportunity 54
6.3 Diagnostic Challenges 54
6.3.1 Unmet Need 54
6.3.2 Gap Analysis 55
6.3.3 Opportunity 55
6.4 Low Treatment Rate and Underdosing of Medications 55
6.4.1 Unmet Need 55
6.4.2 Gap Analysis 57
6.4.3 Opportunity 57
6.5 Unsatisfactory Efficacy and Safety Profiles of Pharmacological Treatments 58
6.5.1 Unmet Need 58
6.5.2 Gap Analysis 59
6.5.3 Opportunity 59
6.6 Elderly Patient Population - Drug Tolerability 60
6.6.1 Unmet Need 60
6.6.2 Gap Analysis 60
6.6.3 Opportunity 61
6.7 Rational or Personalized Therapies 61
6.7.1 Unmet Need 61
6.7.2 Gap Analysis 62
6.7.3 Opportunity 62

7 Pipeline Assessment 64
7.1 Overview 64
7.2 Promising Drugs in Clinical Development 65

8 Topical Clonidine Gel 68
8.1 Overview 68
8.2 Efficacy 69
8.3 Safety 70
8.4 Dosing and Formulation 70
8.5 Potential Clinical and Commercial Positioning 70
8.6 Pricing and Reimbursement 70
8.7 SWOT Analysis 71
8.8 Forecast 71

9 Appendix 73
9.1 Bibliography 73
9.2 Abbreviations 77
9.3 Methodology 81
9.4 Forecasting Methodology 81
9.4.1 Diagnosed PDN, PHN, and TN Patients 81
9.4.2 Percent Drug-Treated Patients 82
9.4.3 General Pricing Assumptions 82
9.4.4 Generic Erosion 82
9.4.5 Pricing of Pipeline Agents 82
9.5 Physicians and Specialists Included in This Study 83
9.6 About the Authors 85
9.6.1 Author 85
9.6.2 Global Head of Healthcare 86
9.7 About GlobalData 87
9.8 Disclaimer 87

List of Tables

Table 1: Classification of NP Syndromes Based on the Site of Somatosensory Damage 15
Table 2: Signs and Symptoms of NP 16
Table 3: Screening Tools for NP 30
Table 4: NP-Related Signs and Symptoms 32
Table 5: Treatment Guidelines for NP 37
Table 6: Recommended Drug Therapies for NP Conditions by Line of Therapy 43
Table 7: Most Prescribed Drugs for NP by Indication and Line of Therapy in the Global Markets, 2012 45
Table 8: NNT and NNH for Classes of Oral Drugs used in NP Treatment, 2013 48
Table 9: Select Products Used for NP Treatment, 2013 50
Table 10: Unmet Need and Opportunity in NP 52
Table 11: NP - Promising Drugs in Clinical Development 66
Table 12: Comparison of Drugs in Development for NP, 2014 66
Table 13: Product Profile - Topical Clonidine Gel 69
Table 14: Topical Clonidine Gel SWOT Analysis, 2013 71
Table 15: Global Sales Forecasts ($) for Topical Clonidine Gel, 2012-2022 72

List of Figures

Figure 1: Nociceptive Versus Neuropathic Pain 14
Figure 2: Etiology and Pathophysiology of NP 19
Figure 3: Pain Pathway - Somatosensory System 22
Figure 4: Pathophysiological Mechanisms of NP at Different Levels of the Nervous System 26
Figure 5: Pathophysiological Targets of NP Drugs 27
Figure 6: NeuSPIG Diagnostic Certainty Algorithm for NP 33
Figure 7: General Treatment Algorithm for NP 42
Figure 8: Competitive Assessment of Mid-to-Late Stage Pipeline Agents in NP, 2012-2022 67