Pipeline Insight: Neuropathic Pain - Emerging Drugs Fail To Capitalize In Lucrative Market : Market Research Report

Pipeline Insight: Neuropathic Pain - Emerging Drugs Fail To Capitalize In Lucrative Market

Published by: Datamonitor

Published: Sep. 26, 2007 - 217 Pages

ABOUT DATAMONITOR HEALTHCARE: About the Central Nervous System pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY: Scope of the analysis; Datamonitor insight into the Neuropathic pain market; Key metrics; Datamonitor Pipeline Assessment Summary; Related reports
CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS: Pipeline overview; Phase II and above; Discontinued and suspended projects; Projects recently suspended or discontinued; Pristiq; Lamictal XR; Gabapentin GR; ACV-1; Namenda (memantine); Traxoprodil; AZD-4282; Key companies involved in the neuropathic pain pipeline; Pfizer; Neurontin; Lyrica; Eli Lilly; Cymbalta; UCB; Vimpat; Brivaracetam; Key R&D company strategies; Reformulation strategies: Gabapentin; Gabapentin GR; XP13512; Patient subgroups
CHAPTER 3 NEUROPATHIC PAIN - MARKET OVERVIEW: Definition of neuropathic pain; Segmentation of neuropathic pain; Segmentation of neuropathic pain differs depending on the geographic market; General neuropathic pain provides a broader customer base in the EU; US approval requires evidence in each neuropathic pain subtype; Major neuropathic pain subtypes; Diabetic neuropathic pain; Post-herpetic neuralgia; HIV neuropathic pain; Neuropathic low-back pain; Other subtypes; Epidemiology; Diabetic neuropathic pain; Post-herpetic neuralgia; HIV neuropathic pain; Post operative pain; Current market overview; Five treatments are currently marketed for neuropathic pain; Off-label prescribing; US dominated market; Unmet need in neuropathic pain; Clinical unmet need
CHAPTER 4 R&D APPROACH: Classification of pipeline products; Glutamate receptor modulators; NMDA; AMPA; Kainate; Ion channel modulators; Sodium channels; Calcium channels; GABA modulators; Monoamine modulators; SNRIs; Dopamine; Others; Cannabinoid agonists; Vanilloid receptor agonists; Substance P release modulators; ACh receptor agonists; NGF modulators; TNF alpha antagonists; Adrenoceptor modulation; Adenosine A2 agonist; Free radicals; Clinical trial design in neuropathic pain; Choice of endpoint is the key clinical trial design factor in neuropathic pain; Head-to-head trials of increasing importance; Lyrica is the choice of ideal comparator drug for head-to-head clinical trials; Length of trial should indicate titration period for physician ease of use; The Initiative on Methods, Measurements and Pain Assessments in Clinical trials (IMMPACT); European Federation of Neurological Societies assessment; Clinical trial endpoints in neuropathic pain; 50% reduction in pain is a primary measure of efficacy; Multiple pain and quality of life assessment questionnaires should be used in trials; Clinical trial drop-out as an endpoint
CHAPTER 5 GLUTAMATE RECEPTOR MODULATORS LATE-STAGE DRUG ANALYSIS & FORECASTS: Overview of glutamate receptor modulators; Pipeline summary; Comparative forecasts; Definition of current comparator therapy; Pfizer's Lyrica is Datamonitor's comparator therapy; Lidoderm is the topical comparator therapy; Zenvia (dextromethorphan & quinidine sulfate); Drug overview; Clinical trial data; Phase III trial; Patient potential; Marketing factors; Satisfaction of unmet needs; Improved efficacy; Improved side effect profile: potential to cause upset; Reduced pill burden; Forecasts to 2016; Datamonitor drug assessment summary; NP-1 (ketamine & amitriptyline); Drug overview; Clinical trial data; Phase II trial; Patient potential; NP-1's topical use attracts a wide treatment range; Potential negative aspects; Marketing factors; Antidepressant topical mechanism of action; Satisfaction of unmet needs; Improved efficacy; Improved side effect profile; Reduced pill burden; Forecasts to 2016; Datamonitor drug assessment summary; CNS-5161; Drug overview; Clinical trial data; Phase IIa trial; Phase I trial; Satisfaction of unmet needs; Improved efficacy; Improved side effect profile; Reduced pill burden; Datamonitor comments; V3381; Clinical trial data; Phase IIa study; Phase I study; Preclinical studies:; Datamonitor comments; Other glutamate receptor modulators; RGH-896; EVT-101; NS-1209; NGX-426; Late-stage development compounds recently discontinued; AZD-9272
CHAPTER 6 ION CHANNEL MODULATORS LATE-STAGE DRUG ANALYSIS AND FORECASTS: Overview of ion channel modulators; Pipeline summary; Comparative forecasts; Definition of current comparator therapy; Vimpat (lacosamide); Drug overview; Clinical trial data; Phase III study; Phase II study; Patient potential; Sodium channels have potential to be lucrative market; Marketing factors; Vimpat is being investigated for epilepsy along with other indications like many neuropathic pain treatments; UCB looks set to become a big player in the CNS market; Satisfaction of unmet needs; Improved efficacy: data promising; Improved side-effect profile; Fewer drug-drug interactions: add to physician confidence in Vimpat; Forecasts to 2016; Datamonitor drug assessment summary; Lamictal XR; Drug overview; Clinical trial data; Phase II Lamictal clinical trial; Phase III; Improved side effect profile: a big problem in neuropathic pain; Forecasts to 2016; Ralfinamide; Drug overview; Clinical trial data; Phase II study results; Phase IIa study; Patient potential; Multiple neuropathic pain indications indicate mechanistic approach; Marketing factors; Satisfaction of unmet needs; Improved efficacy; Reduced time to onset of action; Forecasts to 2016; Datamonitor drug assessment summary; Other ion channel modulators; ABT-894; Bupivacaine (Eladur); Lidocaine patch KN-48; Brivaracetam; Late-stage development compounds recently discontinued; ACV-1
CHAPTER 7 GABA MODULATORS LATE-STAGE DRUG ANALYSIS AND FORECASTS: Overview of GABA receptor modulators; Pipeline summary; Comparative forecasts; Definition of current comparator therapy; Gabapentin GR; Drug overview; Clinical trial data; Phase III study; Phase II study; A future for Gabapentin GR?; Forecasts to 2016; XP13512 gabapentin (Enacarbil); Clinical trial data; Phase IIa; Phase I; Marketing factors - improved duration of action; Patient potential; Satisfaction of unmet needs; Improved efficacy; Reduced pill burden; Forecasts to 2016; Datamonitor drug assessment summary; Other GABA modulators; Retigabine
CHAPTER 8 MONOAMINE MODULATORS LATE-STAGE ANALYSIS AND FORECASTS: Overview of monoamine receptor modulators; Pipeline summary; Definition of current comparator therapy; Pristiq (desvenlafaxine); Drug overview; Clinical trial data; Ongoing trials: Phase III; Phase II Venlafaxine studies; Satisfaction of unmet needs; Forecasts to 2016; Other monoamine modulators; Bicifadine; Reboxetine (+)-(S,S); F13640; Late-stage development compounds recently discontinued; Radafaxine (353162)
CHAPTER 9 OTHER LATE-STAGE DRUG ANALYSIS AND FORECASTS: Overview of other therapies; Pipeline summary; Comparative forecasts; Definition of current comparator therapy; Fentora (fentanyl buccal transmucosal)

Abstract

Introduction

The neuropathic pain market is forecast to double from 2006 to reach over $7 billion by 2016. At this time, the current late-stage neuropathic pain pipeline is forecast to take only 18% of the total market share, highlighting an opportunity for better pipeline drugs that demonstrate improved pain management. The most promising and closest pipeline drug to market is UCB's Vimpat (lacosamide).

Scope

Analysis of patient potential, unmet needs and clinical trial design in neuropathic pain Overview of drugs in late- and early-stage clinical development; with analysis of key companies involved in the market Detailed profiles of key compounds in development for use in neuropathic pain, with indication-specific drug sales forecasts to 2016 Discussion of Pfizer, Eli Lilly and UCB's market strategies and insight from key opinion leaders

Highlights

UCB's increasing CNS portfolio is further bolstered by the imminent arrival of Vimpat on the market. CNS is a key area of investigation for UCB, constituting 39% of their sales in 2006. UCB has further expanded its reach by trialling this anticonvulsant not just for epilepsy but also for neuropathic pain, fibromyalgia, migraine and osteoarthritis. NeurogesX's Transacin (capsaicin) treatment is set to cause a stir in the topical market, currently dominated by Endo's Lidoderm (lidocaine 5% patch). The advantageous 3 monthly dosing regimen coupled with a strong efficacy and safety profile, will see Transacin draw favorable returns in its niche market. Pfizer will continue to be a major contender in neuropathic pain, with the current market leader Lyrica predicted to be an even greater commercial success than its predecessor Neurontin (gabapentin). Pfizer's branded drugs are forecast to capture a substantial 41% of the neuropathic pain market share in 2016.

Reasons to Purchase

Understand unmet needs in the neuropathic pain market based on key opinion leader insight Benchmark key late-stage neuropathic pain compounds against current market leaders Assess the global (US, Japan, five major EU) sales forecasts of key late-stage pipeline drugs; and examine their clinical and commercial potential

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Pipeline Insight: Neuropathic Pain - Emerging Drugs Fail To Capitalize In Lucrative Market

Table of Contents

Abstract