There is increased industry focus on the behavioral symptoms of Alzheimer’s disease (AD), including agitation—and with good reason. Agitation affects the majority of diagnosed AD patients, according to DRG epidemiology, and comprises a constellation of disruptive symptoms for patients and their families. With competing brands from Lundbeck/Otsuka, Avanir/Otsuka, and IntraCellular Therapies (among others) poised to enter the market beginning in 2021, and blockbuster sales at stake, understanding the drivers of clinical decision making in agitation and prescriber perceptions of the risk/benefits of today’s off-label (but generic) options will help identify levers for new product positioning and differentiation in this evolving market.

Questions Answered:

  • What are the treatment drivers and goals for agitation in AD?
  • What attributes are key influencers, which have limited impact, and which are hidden opportunities?
  • How do current therapies perform on key treatment drivers and goals for agitation in AD?
  • What are the prevailing areas of unmet need and opportunity in agitation in AD?
  • What trade-offs across different clinical attributes and price are acceptable to U.S. and European neurologists for a hypothetical new agitation in AD drug?

Markets covered: United States, United Kingdom, France, Germany

Primary research: Survey of 60 U.S. and 30 European neurologists fielded in January 2017

Key companies: Lundbeck, Otsuka Pharmaceutical, Avanir Pharmaceuticals

Key drugs: quetiapine, risperidone, olanzapine, haloperidol, citalopram, arpiprazole, lorazepam, brexpiprazole, AVP-786

Table of contents

  • Alzheimer's Disease - Unmet Need - Detailed, Expanded Analysis: Agitation In Alzheimer's Disease
    • Key Updates
      • November 2017
      • Treatment Drivers and Goals
        • Overview
        • Rationale for Treatment Drivers and Goals Selection
          • Efficacy
          • Safety and Tolerability
        • Physician Rating of Treatment Drivers and Goals in Agitation in Alzheimer's Disease
          • Importance of Efficacy Attributes to Prescribing Decisions in Agitation in Alzheimer's Disease: United States
          • Importance of Efficacy Attributes to Prescribing Decisions in Agitation in Alzheimer's Disease: Europe
          • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Agitation in Alzheimer's Disease: United States
          • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Agitation in Alzheimer's Disease: Europe
        • Stated vs. Derived Importance of Treatment Drivers and Goals
          • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Agitation in Alzheimer's Disease: United States
          • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Agitation in Alzheimer's Disease: Europe
      • Product Performance Against Treatment Drivers and Goals
        • Overview
        • Rationale for Drug Selection
          • Products for Agitation in Alzheimer's Disease
        • Current Brand Performance on Key Treatment Drivers and Goals
          • Overall Performance of Key Therapies for Agitation in Alzheimer's Disease: United States
          • Overall Performance of Key Therapies for Agitation in Alzheimer's Disease: Europe
          • Relative Performance of Key Therapies for Agitation in Alzheimer's Disease Across Select Efficacy Attributes: United States
          • Relative Performance of Key Therapies for Agitation in Alzheimer's Disease Across Select Efficacy Attributes: Europe
          • Relative Performance of Key Therapies for Agitation in Alzheimer's Disease Across Select Safety and Tolerability Attributes: United States
          • Relative Performance of Key Therapies for Agitation in Alzheimer's Disease Across Select Safety and Tolerability Attributes: Europe
      • Assessment of Unmet Need
        • Overview
        • Overall Satisfaction with Current Treatment
          • Surveyed Neurologists’ Satisfaction with the Performance of Key Therapies for Agitation in Alzheimer's Disease on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
          • Surveyed Neurologists’ Satisfaction with the Performance of Key Therapies for Agitation in Alzheimer's Disease on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
        • Physician Rating of Unmet Need in Agitation in Alzheimer's Disease
          • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Agitation in Alzheimer's Disease: United States
          • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Agitation in Alzheimer's Disease: Europe
          • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Agitation in Alzheimer's Disease: United States
          • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Agitation in Alzheimer's Disease: Europe
        • Unmet Need in Agitation in Alzheimer's Disease and Related Indications
          • Surveyed Neurologists' Ascribed Level of Unmet Need in Agitation in Alzheimer's Disease and Related Indications: United States
          • Surveyed Neurologists' Ascribed Level of Unmet Need in Agitation in Alzheimer's Disease and Related Indications: Europe
      • Opportunity Analysis
        • Areas of Opportunity in the Agitation in Alzheimer's Disease Market and Emerging Therapy Insights
          • Opportunity: A Drug Approved for the Treatment of Agitation in Alzheimer's Disease
          • Opportunity: An Approved Therapy for Agitation in Alzheimer's Disease That Does Not Have a Safety Warning for Increased Mortality
      • Target Product Profiles
        • Assessing Drug Development Opportunities
        • Target Product Profile Methodology
          • Attributes and Attribute Levels
        • Attribute Importance and Part-Worth Utilities
          • Agitation in Alzheimer's Disease Target Product Profile: Attribute Importance
          • Improvement on the CMAI at 12 Weeks (placebo-adjusted)
          • Improvement on the NPI at 12 Weeks (placebo-adjusted)
          • Improvement on the ADCS-CGIC at 12 Weeks (placebo-adjusted)
          • Worsening of Cognition: Decline in MMSE Score at 12 Weeks (placebo-adjusted)
          • Presence of a Safety Warning for Increased Mortality in Elderly Dementia Patients
          • Rate of Drug-Induced Falls, fractures, or Injuries (% of patients, placebo-adjusted)
          • Price/Day
        • Conjoint Analysis-Based Simulations of Market Scenarios
          • Agitation in Alzheimer's Disease Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
          • Agitation in Alzheimer's Disease Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
          • Agitation in Alzheimer's Disease Market Simulations: Target Product Profiles Included in Scenario 1
      • Appendix
        • Key Abbreviations
        • Experts Interviewed
        • Bibliography

    Author(s): Tamara Blutstein, PhD

    Tamara Blutstein is a Senior Business Insights Analyst on the Central Nervous System, Pain, and Ophthalmology team. She is responsible for analyzing and forecasting pharmaceutical markets, primarily in Neurology indications, with specific expertise in Alzheimer’s disease, Parkinson’s disease, and ischemic stroke.

    Prior to joining the company, Tamara was a postdoctoral fellow at Tufts University School of Medicine, where she studied the role of gliotransmission in the regulation of sleep and sleep homeostasis. She earned a Ph.D. in neuroscience from the University of Maryland School of Medicine where she conducted research on the role of gonadal hormones in modulating neuronal-glial communication. She holds a B.A. in neuroscience from Drew University.


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