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Eslicarbazepine acetate (Neuropathic Pain) - Forecast and Market Analysis to 2022

Summary

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.

Eslicarbazepine acetate is a drug that was developed by Bial-Portela & Ca., and is currently in Phase III of clinical development for PDN and PHN. It has already been approved for marketing in Europe and the US for the adjunctive treatment of adults with partial epileptic seizures. It was launched in the EU by Bial in conjunction with Eisai in 2009, and received FDA approval in the US in November 2013, where it is being developed and commercialized by Sunovion Pharmaceuticals under the brand name Aptiom.

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 Eslicarbazepine acetate including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Eslicarbazepine acetate 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 Eslicarbazepine acetate performance
- Obtain sales forecast for Eslicarbazepine acetate from 2012-2022 in the top six countries (the US, France, Germany, Italy, Spain and the UK).

Table Of Contents

Eslicarbazepine acetate (Neuropathic Pain) - Forecast and Market Analysis to 2022
1 Table of Contents

2 Introduction 10
2.1 Catalyst 10
2.2 Related Reports 10
3 Disease Overview 12
3.1 Clinical Manifestations of Neuropathic Pain - Signs and Symptoms 14
3.1.1 Painful Diabetic Neuropathy 16
3.1.2 Postherpetic Neuralgia 17
3.1.3 Trigeminal Neuralgia 17
3.2 Etiology and Pathophysiology 18
3.2.1 Etiology 19
3.2.2 Pathophysiology 20
4 Disease Management 28
4.1 Diagnosis and Treatment Overview 28
4.1.1 Diagnosis 28
4.1.2 Treatment Overview and Guidelines 35
5 Competitive Assessment 45
5.1 Overview 45
6 Unmet Need and Opportunity 50
6.1 Overview 50
6.2 Physician Knowledge or Awareness 51
6.2.1 Unmet Need 51
6.2.2 Gap Analysis 52
6.2.3 Opportunity 53
6.3 Diagnostic Challenges 53
6.3.1 Unmet Need 53
6.3.2 Gap Analysis 54
6.3.3 Opportunity 54
6.4 Low Treatment Rate and Underdosing of Medications 54
6.4.1 Unmet Need 54
6.4.2 Gap Analysis 56
6.4.3 Opportunity 56
6.5 Unsatisfactory Efficacy and Safety Profiles of Pharmacological Treatments 57
6.5.1 Unmet Need 57
6.5.2 Gap Analysis 58
6.5.3 Opportunity 58
6.6 Elderly Patient Population - Drug Tolerability 59
6.6.1 Unmet Need 59
6.6.2 Gap Analysis 59
6.6.3 Opportunity 60
6.7 Rational or Personalized Therapies 60
6.7.1 Unmet Need 60
6.7.2 Gap Analysis 61
6.7.3 Opportunity 61
7 Pipeline Assessment 63
7.1 Overview 63
7.2 Promising Drugs in Clinical Development 64
8 Eslicarbazepine Acetate 67
8.1 Overview 67
8.2 Efficacy 68
8.3 Safety 69
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 80
9.4 Forecasting Methodology 80
9.4.1 Diagnosed PDN, PHN, and TN Patients 81
9.4.2 Percent Drug-Treated Patients 81
9.4.3 General Pricing Assumptions 81
9.4.4 Generic Erosion 82
9.4.5 Pricing of Pipeline Agents 82
9.5 Physicians and Specialists Included in This Study 82
9.6 About the Authors 84
9.6.1 Author 84
9.6.2 Global Head of Healthcare 85
9.7 About GlobalData 86
9.8 Disclaimer 86

1.1 List of Tables

Table 1: Classification of NP Syndromes Based on the Site of Somatosensory Damage 14
Table 2: Signs and Symptoms of NP 15
Table 3: Screening Tools for NP 29
Table 4: NP-Related Signs and Symptoms 31
Table 5: Treatment Guidelines for NP 36
Table 6: Recommended Drug Therapies for NP Conditions by Line of Therapy 42
Table 7: Most Prescribed Drugs for NP by Indication and Line of Therapy in the Global Markets, 2012 44
Table 8: NNT and NNH for Classes of Oral Drugs used in NP Treatment, 2013 47
Table 9: Select Products Used for NP Treatment, 2013 49
Table 10: Unmet Need and Opportunity in NP 51
Table 11: NP - Promising Drugs in Clinical Development 65
Table 12: Comparison of Drugs in Development for NP, 2014 65
Table 13: Product Profile - Eslicarbazepine Acetate 67
Table 14: Phase II: Efficacy of Eslicarbazepine Acetate in PHN 68
Table 15: Phase II: Efficacy of Eslicarbazepine Acetate in PDN 69
Table 16: Eslicarbazepine Acetate SWOT Analysis, 2013 71
Table 17: Global Sales Forecasts ($m) for Eslicarbazepine Acetate, 2012-2022 72

1.2 List of Figures

Figure 1: Nociceptive Versus Neuropathic Pain 13
Figure 2: Etiology and Pathophysiology of NP 18
Figure 3: Pain Pathway - Somatosensory System 21
Figure 4: Pathophysiological Mechanisms of NP at Different Levels of the Nervous System 25
Figure 5: Pathophysiological Targets of NP Drugs 26
Figure 6: NeuSPIG Diagnostic Certainty Algorithm for NP 32
Figure 7: General Treatment Algorithm for NP 41
Figure 8: Competitive Assessment of Mid-to-Late Stage Pipeline Agents in NP, 2012-2022 66

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