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Several antipsychotic therapies are available for the treatment of schizophrenia and primarily control the positive symptoms of the disease. However, given that a sizable portion of schizophrenia patients do not respond adequately to current antipsychotics and that treatment is highly individualized, multiple drug development opportunities exist in this market. With the entry of newer long-acting depot atypical antipsychotics (e.g., Janssen’s Invega Trinza / Trevicta) and oral antipsychotics (e.g., Allergan / Gedeon Richter / Recordati’s Vraylar / Reagila), it is essential to understand how psychiatrists perceive the performance of current therapies and to determine the greatest areas of unmet need in this space. Moreover, with the anticipated availability of new therapies in the near future (e.g., Alkermes’s ALKS-3831), it is important to evaluate the remaining areas of opportunity in this market.

QUESTIONS ANSWERED

  • How do psychiatrists rate current antipsychotics as performing on key treatment drivers and goals for the positive symptoms of schizophrenia?
  • Which attributes are key influencers, which have limited impact, and which are hidden opportunities in the positive symptoms of schizophrenia?
  • What are the prevailing areas of unmet need and opportunity in the treatment of the positive symptoms of schizophrenia?
  • What trade-offs across key drug attributes and price are acceptable to psychiatrists for a hypothetical new drug for the positive symptoms of schizophrenia?

CONTENT HIGHLIGHTS

Geographies: United States, France, Germany, United Kingdom

Primary Research: Survey of 60 U.S. and 33 European psychiatrists

Key Drugs Covered: Invega Sustenna / Xeplion, Invega Trinza / Trevicta, paliperidone palmitate six-month depot, Rexulti / Rxulti, Vraylar / Reagila, ALKS-3831, lumateperone, pimavanserin, Abilify Maintena, aripiprazole, olanzapine, risperidone

Key Metrics Included:

  • Target Product Profile (TPP) simulator based on conjoint analysis methodology.
  • Stated versus derived importance of product attributes on prescribing behavior.
  • Assessment of current drug performance against treatment drivers and goals.
  • Physician perceptions of unmet needs in the indication and related indications.
  • Analysis of remaining drug development opportunities.

PRODUCT DESCRIPTION

Unmet Need supports clinical development decisions by identifying key attributes and assessing areas of unmet need for a specific disease or subpopulation. Based on surveys with U.S. and European physicians, this report provides insight into key treatment drivers and goals, the performance of current therapies, and the remaining commercial opportunities. Two market scenarios are profiled in detail by DRG experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.

Table of contents

  • Schizophrenia - Unmet Need - Detailed, Expanded Analysis (Positive Symptoms)
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Efficacy
        • Safety and Tolerability
        • Convenience of Administration
        • Nonclinical Factors
      • Rationale for Drug Selection
        • Products for Positive Symptoms of Schizophrenia
    • Treatment Drivers and Goals
      • Key Findings: Attribute Importance
      • Relative Importance of Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Surveyed Psychiatrists' Prescribing Decisions in Positive Symptoms of Schizophrenia
      • Importance of Efficacy Attributes to Prescribing Decisions in Positive Symptoms of Schizophrenia: United States
      • Importance of Efficacy Attributes to Prescribing Decisions in Positive Symptoms of Schizophrenia: Europe
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Positive Symptoms of Schizophrenia: United States
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Positive Symptoms of Schizophrenia: Europe
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in Positive Symptoms of Schizophrenia: United States
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in Positive Symptoms of Schizophrenia: Europe
      • Importance of Nonclinical Factors to Prescribing Decisions in Positive Symptoms of Schizophrenia: United States
      • Importance of Nonclinical Factors to Prescribing Decisions in Positive Symptoms of Schizophrenia: Europe
      • Key Findings: Stated vs. Derived Importance
      • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Positive Symptoms of Schizophrenia: United States
      • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Positive Symptoms of Schizophrenia: Europe
    • Product Performance Against Treatment Drivers and Goals
      • Key Findings
      • Overall Performance of Key Therapies for Positive Symptoms of Schizophrenia: United States
      • Overall Performance of Key Therapies for Positive Symptoms of Schizophrenia: Europe
      • Mean Overall Performance of Key Therapies for Positive Symptoms of Schizophrenia: United States and Europe
      • Relative Performance of Key Therapies for Positive Symptoms of Schizophrenia Across Select Efficacy Attributes: United States
      • Relative Performance of Key Therapies for Positive Symptoms of Schizophrenia Across Select Efficacy Attributes: Europe
      • Relative Performance of Key Therapies for Positive Symptoms of Schizophrenia Across Select Safety and Tolerability Attributes: United States
      • Relative Performance of Key Therapies for Positive Symptoms of Schizophrenia Across Select Safety and Tolerability Attributes: Europe
      • Relative Performance of Key Therapies for Positive Symptoms of Schizophrenia Across Select Convenience of Administration Attributes: United States
      • Relative Performance of Key Therapies for Positive Symptoms of Schizophrenia Across Select Convenience of Administration Attributes: Europe
      • Relative Performance of Key Therapies for Positive Symptoms of Schizophrenia Across Select Nonclinical Attributes: United States
      • Relative Performance of Key Therapies for Positive Symptoms of Schizophrenia Across Select Nonclinical Attributes: Europe
    • Assessment of Unmet Need
      • Surveyed Psychiatrists’ Satisfaction with the Performance of Key Therapies for Positive Symptoms of Schizophrenia on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
      • Surveyed Psychiatrists’ Satisfaction with the Performance of Key Therapies for Positive Symptoms of Schizophrenia on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Positive Symptoms of Schizophrenia: United States
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Positive Symptoms of Schizophrenia: Europe
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Positive Symptoms of Schizophrenia: United States
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Positive Symptoms of Schizophrenia: Europe
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Positive Symptoms of Schizophrenia: United States
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Positive Symptoms of Schizophrenia: Europe
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Positive Symptoms of Schizophrenia: United States
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Positive Symptoms of Schizophrenia: Europe
      • Key Findings: Unmet Need in Positive Symptoms of Schizophrenia and Related Indications
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need in Positive Symptoms of Schizophrenia and Related Indications: United States
      • Surveyed Psychiatrists' Ascribed Level of Unmet Need in Positive Symptoms of Schizophrenia and Related Indications: Europe
    • Opportunity Analysis
      • Areas of Opportunity in the Positive Symptoms of Schizophrenia Market and Emerging Therapy Insights
        • Opportunity: A Therapy Offering Lower Risk of Significant Weight Gain in Patients with the Positive Symptoms of Schizophrenia
        • Opportunity: A Therapy Offering Greater Patient Acceptance in Treating the Positive Symptoms of Schizophrenia
        • Opportunity: A Therapy Offering Greater Improvement in Total Symptom Severity Among Partial Responders to Current Antipsychotics
        • Opportunity: A Therapy Offering Lower Relapse Rate During Long-Term Maintenance Treatment in Patients with the Positive Symptoms of Schizophrenia
    • Target Product Profiles
      • Assessing Drug Development Opportunities
      • Target Product Profile Methodology
        • Attributes and Attribute Levels
        • Attributes of Key Current and Late-Phase Emerging Therapies for the Positive Symptoms of Schizophrenia
      • Attribute Importance and Part-Worth Utilities
        • Positive Symptoms of Schizophrenia Target Product Profile: Attribute Importance
        • Mean Change from Baseline in PANSS Positive Subscale Score at Week 12
        • Mean Change from Baseline in PANSS Total Score at Week 12
        • Relapse During Long-Term Maintenance: % of Patients Who Relapse ≤ 1 Year
        • % of Patients With ≥ 7% Increase from Baseline in Body Weight at 6 Months
        • Long-Term Tolerability: % of Patients Ceasing Therapy Due to AEs ≤ 1 Year
        • Delivery Profile
        • Price per Treated Day Relative to Invega Sustenna / Xeplion
      • Conjoint Analysis-Based Simulations of Market Scenarios
        • Positive Symptoms of Schizophrenia Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
        • Positive Symptoms of Schizophrenia Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
        • Positive Symptoms of Schizophrenia Market Simulations: Target Product Profiles Included in Scenario 1
        • Positive Symptoms of Schizophrenia Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
        • Positive Symptoms of Schizophrenia Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
        • Positive Symptoms of Schizophrenia Market Simulations: Target Product Profiles Included in Scenario 2
    • Appendix
      • Key Abbreviations
      • Experts Interviewed
      • Bibliography

Author(s): Himanshu Jain, M.S. Pharm

Himanshu joined the CNS / ophthalmology team at Decision Resources Group in 2016. He has authored content for psychiatry and ophthalmology (retinal / nonretinal) indications, including schizophrenia, age-related macular degeneration, diabetic retinopathy / diabetic macular edema, dry eye disease, glaucoma, and uveitis.

Himanshu has more than ten years of experience working in market research and consulting firms, and has managed multiple market assessment projects, including bottom-up forecasts, across multiple therapy areas. He holds a M.S. degree in Pharmacology and Toxicology from the National Institute of Pharmaceutical Education and Research in India and an Executive Post-Graduate Diploma in International Business from the Indian Institute of Foreign Trade.


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