R&D Trends: Neuropathic Pain - Extensive and diverse pipeline driven by high unmet need

Introduction

Two key events occurred in the first half of 2011: Gralise (extended-release gabapentin; Depomed) obtained US Food and Drug Administration (FDA) approval for the treatment of post-herpetic neuralgia (PHN) in January 2011. Depomed expects to launch the drug in Q4 2011. Secondly, Horizant (gabapentin enacarbil; XenoPort/GlaxoSmithKline) obtained orphan drug status in the US for PHN in June 2011.

Features and benefits

* Analysis of key R&D dynamics in the drug development pipeline for neuropathic pain.
* Evaluation of the target product profile for future neuropathic pain treatments.
* Summary of clinical trial design in neuropathic pain.
* Identification of the most innovative pharmacological targets in early-stage development.
* Exploration of how the treatment landscape for neuropathic pain may change in the next 20 years.

Highlights

The neuropathic pain pipeline is one of the most extensive in the central nervous system arena, and industry interest in has grown in recent years. Datamonitor considers this to be a reflection of the prevailingly high level of unmet need in the management of neuropathic pain.
A wide variety of novel mechanisms of action are under investigation in the clinical pipeline, reflecting the heterogeneity of neuropathic pain conditions and the limitations in the current understanding of the most appropriate mechanisms to target.
The future of neuropathic pain management will involve the increased use of combination therapies to provide optimum pain relief. Through increased understanding of the etiology of neuropathic pain conditions and the identification of biomarkers and likely responders to treatment, personalized therapy options will provide improved pain relief.

Your key questions answered

* How many drugs are in clinical development for the treatment of neuropathic pain? How does this compare to other pain indications?
* What are the key trends in the neuropathic pain pipeline in terms of mechanisms of action under investigation and neuropathic subtypes being targeted?
* What key companies are involved in the pipeline? What encourages and deters companies from investing in this area?
* What is the clinical gold standard and how do new candidates have to compare to this to successfully penetrate the market?
* How is the treatment of neuropathic pain likely to evolve over the next 10 to 20 years?
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Executive Summary
Strategic scoping and focus
Datamonitor key findings
Related reports
OVERVIEW
Catalyst
Summary
CLINICAL PIPELINE OVERVIEW
Datamonitor has identified 79 separate programs in clinical development
Emerging features of the neuropathic pain pipeline
Pipeline activity indicates substantial and growing industry interest
Phase II is the most populous phase of development as candidates are assessed for a secondary indication
Most commonly targeted indications include diabetic neuropathic pain and post-herpetic neuralgia
Oral therapies dominate the pipeline
A diverse range of target mechanisms are under investigation
Companies involved in the neuropathic pain clinical pipeline
Small, specialist pharmaceutical companies dominate the clinical pipeline
Late-stage development compounds recently discontinued
Three late-stage candidates in the neuropathic pain pipeline have been discontinued since 2009
TARGET PRODUCT PROFILE
Lyrica (pregabalin; Pfizer)
Pfizer’s Lyrica is Datamonitor’s comparator therapy for non-topical neuropathic pain treatments
Clinical trial data for Lyrica
Lidoderm (5% lidocaine patch; Endo/Grünenthal/Teikoku)
Endo’s Lidoderm is Datamonitor’s topical comparator therapy
Clinical trial data for Lidoderm
Target product profile versus current level of attainment
Pipeline candidates need to address efficacy and side effects while being convenient and cost-effective
Consequences of inadequately treated neuropathic pain
CLINICAL TRIAL DESIGN IN NEUROPATHIC PAIN
R&D approach differs depending on the geographic market in which approval is sought
General neuropathic pain provides a broader customer base in the EU and Japan
US approval requires evidence of efficacy and safety in each neuropathic pain subtype
Typical trial design in neuropathic pain
Although regulatory approval differs between regions, clinical trial design remains the same
Choice of endpoint is the key clinical trial design factor in neuropathic pain
Commonly used clinical trial endpoints in neuropathic pain
A key challenge inherent in neuropathic pain clinical trials is recruitment of a homogenous, treatment-naïve patient population
Future developments in clinical trial design
Selective patient recruitment will reduce costs while increasing the likelihood of demonstrating efficacy
Although costly, head-to-head trials are of increasing importance to clarify efficacy
INNOVATIVE EARLY-STAGE APPROACHES
Gene expression inhibitors
Background
Clinical trials are required to confirm promising preclinical data
Genetic approaches have the potential to target peripheral receptors devoid of central side effects
Glial cell modulators
Background
Despite trial setbacks, glial cells provide numerous novel targets for the management of neuropathic pain
Enkephalinase inhibitors
Background
Efficacy has yet to be demonstrated and the potential for central side effects remains a concern
THE FUTURE OF TREATMENT IN NEUROPATHIC PAIN
Use of combination therapies is expected to increase in the future
Increasing use of combination therapies will provide more efficacious treatment options
Pipeline candidates will benefit from improving upon the convenience of administration of available treatments
Fewer drug-drug interactions will strengthen pipeline agents’ profile for use as an adjunctive therapy
Targeting niche indications represents a key commercial opportunity
Niche indications provide a viable and less competitive entry point to the market
Financial incentives and accelerated market access for orphan drugs targeting rare diseases
Emerging technologies will provide treatment options for refractory patients
Developmental advancements for emerging technologies indicate promise
Uptake of emerging technologies will be limited by cost, but third-line treatment option is viable if efficacious
Identification of likely responders will lead to personalized treatments
Research into the etiology of neuropathic pain is essential for the development of targeted treatments
Despite complexities, biomarkers have potential utility for drug development and treatment evaluation
BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports
APPENDIX
Contributing experts
Conferences attended
Report methodology
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