Stakeholder Opinions: Restless Legs Syndrome Novel drugs to prosper as lifecycle management strategies fail

Content

• About Datamonitor Healthcare
  • About The CNS Pharmaceutical Analysis Team
• Chapter 1 Executive Summary
  • Scope of Analysis
  • Datamonitor Insight into The Restless Legs Syndrome Market
  • Contributing Experts
  • Related Reports
  • Upcoming Reports
• Chapter 2 Disease Overview
  • Definition of Restless Legs Syndrome
  • Features and Symptoms of Restless Legs Syndrome
  • Primary Features of Restless Legs Syndrome:
  • Associated Features of Restless Legs Syndrome:
  • Segmentation of Restless Legs Syndrome
  • Severity of Restless Legs Syndrome
  • International Restless Legs Syndrome Study Group Rating Scale (Irls)
  • Co-Morbidities
  • Etiology of Restless Legs Syndrome
  • Primary and Secondary Restless Legs Syndrome
  • Idiopathic Restless Legs Syndrome Is The Most Prevalent Form of The Disease
  • Causes of Restless Legs Syndrome
  • Restless Legs Syndrome Could Result from Dopaminergic Dysfunction and Iron Deficiency
  • Prevalence of Restless Legs Syndrome
  • 15.5 Million Medically Significant Restless Legs Syndrome Patients across The Seven Major Markets
  • Datamonitor's Methodology of Prevalence Rate Estimates
  • Medically Significant Restless Legs Syndrome Accounts for around 30% of The Restless Legs Syndrome Population
  • Prevalence of Restless Legs Syndrome Is Higher in The US and 5eu than in Japan
  • Restless Legs Syndrome Is Higher in Women and Increases with Age
  • Presentation and Diagnosis of Restless Legs Syndrome
  • Disparity between US and 5eu Markets Points to Significant Differences between Presentation, Diagnosis and Treatment Rates
  • Presentation of Restless Legs Syndrome
  • around 60% of Patients with Restless Legs Syndrome Present to A Physician
  • Diagnosis
  • Less than 25% of Patients Who Reported Consulting A Physician for Their Symptoms Received A Diagnosis of Restless Legs Syndrome
  • Underdiagnosis Is Primarily Due to A Lack of Syndrome Awareness
  • Patients Are Often Referred to A Neurologist for An Accurate Diagnosis
  • to Receive A Diagnosis Patients Must Meet All Four Primary Features of Restless Legs Syndrome
  • Laboratory Tests Can Support The Correct Diagnosis of Restless Legs Syndrome
  • Treatment Guidelines for Restless Legs Syndrome
  • Restless Legs Syndrome Treatment Algorithm
  • Physical and Behavioral Treatment
  • Pharmacological Management of Restless Legs Syndrome
  • Dopamine Agonists Are The First-Line Choice
  • Levodopa Use Is Limited by The Risk of Augmentation
  • Anticonvulsants Are Typically Used in Treatment-Resistant Restless Legs Syndrome
  • Opioids Can Be Useful for Treatment-Resistant, Painful Restless Legs Syndrome
  • Hypnotics May Alleviate Sleep Disturbance
  • Iron Infusion Poses A Potential Risk to Restless Legs Syndrome Revenues
• Chapter 3 Unmet Needs
  • Overview of The Key Unmet Needs
  • Key Unmet Needs Description
  • Greater Efficacy without Augmentation
  • Long-Term Efficacy Remains An Unproven Entity Even for Approved Therapies
  • Augmentation with Dopaminergic Treatments Represent A Significant Issue
  • Faster Onset of Action
  • Patients with Occasional Daytime Symptoms Would Benefit Greatly from A More Rapid Onset of Action
  • Longer Duration of Action
  • Extended Release and Patch Formulations Represent Potential to Provide Continuous Low-Dose Treatment
  • Improved Side-Effect Profile
  • Products with An Improved Side-Effect Profile Will Open up The Mild Restless Legs Syndrome Market
  • Effective Second-Line Treatment
  • Clinical Evidence Will Promote The Availability of Dopamine Agonist Alternatives
  • No or Shorter Titration
  • A Shorter Titration Would Represent A Minor Advantage over Current Treatments
• Chapter 4 Current Market Dynamics
  • Market Overview
  • Significant Growth of The Restless Legs Syndrome Market LED by Dopamine Agonist Treatments
  • Requip and Mirapex: The Two Leading Restless Legs Syndrome Brands
  • US Market Accounts for 90% of Restless Legs Syndrome Sales Revenue across The Seven Major Markets
  • The Low 5eu Market Value Compared to The US Is Likely Due to A Greater Awareness of The Disease in The US
  • The Japanese Market May Suffer from The Lack of Recognition of The Disease and The Lack of Legitimacy of Dopamine Agonists for Restless Legs Syndrome
  • Disparity of Current Therapies across Regions
  • Current Therapies
  • Requip
  • Drug Overview
  • Brand Dynamics
  • Clinical Trial Data
  • Datamonitor Comment
  • Mirapex
  • Drug Overview
  • Brand Dynamics
  • Clinical Trial Data
  • Datamonitor Comment
  • Qualaquin (Quinine)
  • Drug Overview
  • Brand Dynamics
  • Datamonitor Comment
  • Neurontin (Gabapentin)
  • Drug Overview
  • Brand Dynamics
  • Datamonitor Comment
• Chapter 5 Pipeline Analysis
  • Restless Legs Syndrome Pipeline Overview in 2008
  • Pre-Registration Pipeline Drugs
  • Neupro and Solzira, The next Two Leading Brands in The Restless Legs Syndrome Market
  • Neupro (Rotigotine Patch)
  • Drug Overview
  • Clinical Trial Data
  • Datamonitor Comment
  • Nenad (Lisuride Transdermal Patch)
  • Drug Overview
  • Clinical Trial Data
  • Datamonitor Comment
  • Solzira (Gabapentin Enacarbil)
  • Drug Overview
  • Clinical Trial Data
  • Datamonitor Comment
  • Other Pipeline Drugs of Note
  • Aplindore
  • Clinical Trial Data
  • Datamonitor Comments
  • Lyrica (Pregabalin)
  • Ongoing Clinical Trial
  • Datamonitor Comment
  • Ropinirole Transdermal Gel Jzp-7
  • Datamonitor Comments
  • Rotigotine Nasal Spray
  • Clinical Trial Data
  • Datamonitor Comments
  • Recently Discontinued Pipeline Drugs
  • Safinamide
  • Bibliography
  • Journals
  • Websites
  • Annual Reports
  • Datamonitor Reports
• Appendix
  • Data Definitions, Limitations and Assumptions
  • Standard Units
  • Japanese Market Data
  • about Datamonitor
  • about Datamonitor Healthcare
  • about The Central Nervous System Analysis Team
  • Disclaimer
• List of Tables
  • Table 1: The International Restless Legs Syndrome Study Group Rating Scale
  • Table 2: Prevalence of Restless Legs Syndrome (Rls) in The US, Japan and 5eu, 2008
  • Table 3: Datamonitor's Estimation of Restless Legs Syndrome (Rls) Prevalence Rates across The Seven Major Markets, 2008
  • Table 4: Prevalence of Restless Legs Syndrome (Rls) Symptoms at Any Frequency across Studies
  • Table 5: Prevalence of Medically Significant Restless Legs Syndrome (Rls) across Studies
  • Table 6: Disparity between US and 5eu Restless Legs Syndrome Market Values and Volumes
  • Table 7: Disparity between US and 5eu Restless Legs Syndrome (Rls) Population Sizes
  • Table 8: Restless Legs Syndrome (Rls)-Specific Sales ($000s) of The Current Prescribed Therapies across The Seven Major Markets, 2004-07
  • Table 9: Requip - Drug Profile, 2008
  • Table 10: Mirapex - Drug Profile, 2008
  • Table 11: Qualaquin - Drug Profile, 2008
  • Table 12: Neurontin - Drug Profile, 2008
  • Table 13: Pipeline Drugs for Restless Legs Syndrome (Rls), 2008
  • Table 14: Efficacy of The Pre-Registration Drugs Assessed by Comparing Decrease in Irls Scores
  • Table 15: Clinical Trial Summary for Neupro (Rotigotine Patch) in Restless Legs Syndrome (Rls), 2008
  • Table 16: Clinical Trial Summary for Nenad (Lisuride Transdermal Patch) in Restless Legs Syndrome (Rls), 2008
  • Table 17: Clinical Trial Summary for Solzira (Gabapentin Enacarbil) in Restless Legs Syndrome (Rls), 2008
  • Table 18: Periodic Limb Movement Index (Plmi) during Sleep
• List of Figures
  • Figure 1: Estimated Projection of The Proportion of Individuals with Restless Legs Syndrome (Rls) Classified as Having A Medically Significant Diagnosis, 2008-2045
  • Figure 2: Prevalence Rates (%) and Number of Restless Legs Syndrome (Rls) Sufferers in The 5eu by Age Group, 2008
  • Figure 3: Datamonitor's Assessment of The Difference between The US and 5eu Restless Legs Syndrome (Rls) Market Values
  • Figure 4: Datamonitor's Restless Legs Syndrome (Rls) Treatment Algorithm, 2008
  • Figure 5: Key Unmet Needs in Restless Legs Syndrome (Rls) Treatment, 2008
  • Figure 6: Restless Legs Syndrome (Rls)-Specific Sales ($M) by Class across The Seven Major Markets, 2004-07
  • Figure 7: Restless Legs Syndrome (Rls)-Specific Sales Volume (IMS Standard Units) by Class across The Seven Major Markets, 2004-07
  • Figure 8: Restless Legs Syndrome (Rls)-Specific Sales Value ($M) by Leading Brands across The Seven Major Markets, 2007
  • Figure 9: Restless Legs Syndrome (Rls)-Specific Sales Revenue ($M) in The US, Japan and 5eu, 2007
  • Figure 10: Restless Legs Syndrome (Rls) Market Value ($M) Share by Product, across The US, 5eu and Japan, 2007
  • Figure 11: Requip (Ropinirole) Restless Legs Syndrome (Rls)-Specific Sales ($000s) across The Seven Major Markets, 2004-07
  • Figure 12: Requip (Ropinirole) Restless Legs Syndrome (Rls)-Specific Sales ($M) Distribution across The Seven Major Markets, 2007
  • Figure 13: Datamonitor's Assessment of Glaxosmithkline's Strategy in Restless Legs Syndrome, 2008
  • Figure 14: Datamonitor's Assessment of Glaxosmithkline's Development of Two Different Extended-Release Formulations of Requip for Restless Legs Syndrome and Parkinson's Disease
  • Figure 15: Datamonitor's Conceptual Representation of The Pharmacokinetic Profiles for Requip IR and Requip Xl in Restless Legs Syndrome Patients
  • Figure 16: Mirapex (Pramipexole) Restless Legs Syndrome-Specific Sales ($000s) across The Seven Major Markets, 2004-07
  • Figure 17: Mirapex (Pramipexole) Restless Legs Syndrome (Rls)-Specific Sales ($M) Distribution across The Seven Major Markets, 2007
  • Figure 18: Qualaquin (Quinine) Restless Legs Syndrome (Rls)-Specific Sales ($000s) across The Seven Major Markets, 2004-07
  • Figure 19: Neurontin (Gabapentin) Restless Legs Syndrome (Rls)-Specific Sales ($000s) across The Seven Major Markets, 2004-07
  • Figure 20: Neurontin (Gabapentin) Restless Legs Syndrome-Specific Sales Distribution across The Seven Major Markets ($M), 2007