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Lidoderm/Versatis (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.

Lidoderm, the topical analgesic 5% lidocaine patch (medicated plaster), was invented by US pharmacist Harry Hind (Hind Healthcare) and was approved by the FDA in March 1999 for the treatment of PHN. Teikoku Seiyaku then assumed from Hind full responsibility for manufacture of the Lidoderm patch, while Endo Pharmaceuticals has the rights to market the patch in the US. The patch was launched by Endo in the US in September 1999 for the treatment of PHN. In Europe, the patch was co-developed by Teikoku and the German drug company, Grünenthal, and was launched in the EU in 2007 under the brand name Versatis.

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

Table Of Contents

Lidoderm/Versatis (Neuropathic Pain) - Forecast and Market Analysis to 2022
1 Table of Contents

2 Introduction 9
2.1 Catalyst 9
2.2 Related Reports 9
3 Disease Overview 11
3.1 Clinical Manifestations of Neuropathic Pain - Signs and Symptoms 13
3.1.1 Painful Diabetic Neuropathy 15
3.1.2 Postherpetic Neuralgia 16
3.1.3 Trigeminal Neuralgia 16
3.2 Etiology and Pathophysiology 17
3.2.1 Etiology 18
3.2.2 Pathophysiology 19
4 Disease Management 27
4.1 Diagnosis and Treatment Overview 27
4.1.1 Diagnosis 27
4.1.2 Treatment Overview and Guidelines 34
5 Competitive Assessment 44
5.1 Overview 44
6 Lidoderm/Versatis 49
6.1 Overview 49
6.2 Efficacy 50
6.3 Safety 51
6.4 SWOT Analysis 51
6.5 Forecast 52
7 Appendix 54
7.1 Bibliography 54
7.2 Abbreviations 58
7.3 Methodology 61
7.4 Forecasting Methodology 61
7.4.1 Diagnosed PDN, PHN, and TN Patients 61
7.4.2 Percent Drug-Treated Patients 62
7.4.3 General Pricing Assumptions 62
7.4.4 Individual Drug Assumptions 63
7.4.5 Generic Erosion 63
7.5 Physicians and Specialists Included in This Study 64
7.6 About the Authors 65
7.6.1 Author 65
7.6.2 Global Head of Healthcare 66
7.7 About GlobalData 67
7.8 Disclaimer 67

1.1 List of Tables

Table 1: Classification of NP Syndromes Based on the Site of Somatosensory Damage 13
Table 2: Signs and Symptoms of NP 14
Table 3: Screening Tools for NP 28
Table 4: NP-Related Signs and Symptoms 30
Table 5: Treatment Guidelines for NP 35
Table 6: Recommended Drug Therapies for NP Conditions by Line of Therapy 41
Table 7: Most Prescribed Drugs for NP by Indication and Line of Therapy in the Global Markets, 2012 43
Table 8: NNT and NNH for Classes of Oral Drugs used in NP Treatment, 2013 46
Table 9: Select Products Used for NP Treatment, 2013 48
Table 10: Product Profile - Lidoderm/Versatis 50
Table 11: Lidoderm/Versatis SWOT Analysis, 2013 51
Table 12: Global Sales Forecasts ($m) for Lidoderm/Versatis, 2012-2022 53

1.2 List of Figures

Figure 1: Nociceptive Versus Neuropathic Pain 12
Figure 2: Etiology and Pathophysiology of NP 17
Figure 3: Pain Pathway - Somatosensory System 20
Figure 4: Pathophysiological Mechanisms of NP at Different Levels of the Nervous System 24
Figure 5: Pathophysiological Targets of NP Drugs 25
Figure 6: NeuSPIG Diagnostic Certainty Algorithm for NP 31
Figure 7: General Treatment Algorithm for NP 40

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