Numerous antidepressant therapies are available to treat major depressive disorder (MDD), many of which have long been generic and are entrenched in medical practice. However, most current therapies suffer from shortcomings in efficacy and/or safety and tolerability, resulting in inadequate patient response and remission rates and creating opportunities for new, improved therapies for treatment-resistant depression (TRD). Although newer-to-market agents such as Lundbeck / Takeda’s Trintellix / Brintellix (vortioxetine) and Janssen’s Spravato (esketamine) have expanded the armamentarium of therapeutic options and, in the case of Spravato, provided a novel, fast-acting option, unmet need remains for new therapies. This report provides quantitative insight into psychiatrists’ perceptions of key treatment drivers and goals and assesses the current level of unmet need and opportunity in the treatment of TRD.

QUESTIONS ANSWERED

  • What are the treatment drivers and goals for TRD?
  • What are surveyed psychiatrists’ opinions of the relative performance of select therapies, including Trintellix / Brintellix (Lundbeck / Takeda), Spravato (Janssen), and aripiprazole (Otsuka Pharmaceutical’s Abilify, generics) on key efficacy, safety / tolerability, and convenience of administration attributes?
  • What drug attributes are key influencers, which have limited impact, and which are hidden opportunities?
  • What trade-offs across different clinical attributes and prices are acceptable to U.S. and European psychiatrists for a hypothetical new drug to treat TRD?

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. One market scenario is profiled in detail by DRG experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.

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

Primary research: Survey of 60 U.S. and 30 European psychiatrists fielded in May 2020.

Key companies: AstraZeneca, Eli Lilly, Janssen, Lundbeck, Otsuka Pharmaceutical, Takeda Pharmaceuticals

Key drugs: Aripiprazole, bupropion SR, duloxetine, quetiapine XR, Rexulti, Spravato, Trintellix / Brintellix

Key metrics provided:

  • 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.

Table of contents

  • Unipolar Depression - Unmet Need - Detailed, Expanded Analysis - Treatment-Resistant Depression (US & EU) - 2020
    • Executive Summary
      • Unmet Need - TRD - Executive Summary - August 2020
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Rationale for Drug Selection
        • 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 TRD
          • Importance of Efficacy Attributes to Prescribing Decisions in TRD: United States
          • Importance of Efficacy Attributes to Prescribing Decisions in TRD: Europe
          • Importance of Safety and Tolerability Attributes to Prescribing Decisions in TRD: United States
          • Importance of Safety and Tolerability Attributes to Prescribing Decisions in TRD: Europe
          • Importance of Convenience of Administration Attributes to Prescribing Decisions in TRD: United States
          • Importance of Convenience of Administration Attributes to Prescribing Decisions in TRD: 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 TRD: United States
          • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in TRD: Europe
        • Product Performance Against Treatment Drivers and Goals
          • Key Findings
          • Overall Performance of Key Therapies for TRD: United States
          • Overall Performance of Key Therapies for TRD: Europe
          • Mean Overall Performance of Key Therapies for TRD: United States and Europe
          • Relative Performance of Key Therapies for TRD Across Select Efficacy Attributes: United States
          • Relative Performance of Key Therapies for TRD Across Select Efficacy Attributes: Europe
          • Relative Performance of Key Therapies for TRD Across Select Safety and Tolerability Attributes: United States
          • Relative Performance of Key Therapies for TRD Across Select Safety and Tolerability Attributes: Europe
          • Relative Performance of Key Therapies for TRD Across Select Convenience of Administration Attributes: United States
          • Relative Performance of Key Therapies for TRD Across Select Convenience of Administration Attributes: Europe
        • Assessment of Unmet Need
          • Key Findings: Unmet Need in TRD
          • Surveyed Psychiatrists' Satisfaction with the Performance of Key Therapies for TRD on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
          • Surveyed Psychiatrists' Satisfaction with the Performance of Key Therapies for TRD on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
          • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in TRD: United States
          • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in TRD: Europe
          • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in TRD: United States
          • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in TRD: Europe
          • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in TRD: United States
          • Surveyed Psychiatrists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in TRD: Europe
          • Key Findings: Unmet Need in TRD and Related Indications
          • Surveyed Psychiatrists' Ascribed Level of Unmet Need in TRD and Related Indications: United States
          • Surveyed Psychiatrists' Ascribed Level of Unmet Need in TRD and Related Indications: Europe
        • Opportunity Analysis
          • Areas of Opportunity in the TRD Market and Emerging Therapy Insights
            • Opportunity: A Novel Therapy Offering a Faster Time to Onset of Therapeutic Effect
            • Opportunity: A Novel Therapy Offering Improvements on Multiple Key Efficacy Measures
        • Target Product Profiles
          • Assessing Drug Development Opportunities
          • Target Product Profile Methodology
            • Attributes and Attribute Levels
          • Attribute Importance and Part-Worth Utilities
            • TRD Target Product Profile: Attribute Importance
            • MADRS Score Improvement on Depressive Symptoms as Adjunct to ADT Therapy
            • CGI-S Score Improvement as Adjunct to ADT Therapy
            • Time to Onset of Therapeutic Effect as Adjunct to ADT Therapy
            • Incidence of Neurological Side Effects as Adjunct to ADT Therapy
            • Risk of ≥ 7% Weight Gain as Adjunct to ADT Therapy
            • Delivery Profile
            • Price per Treated Day
          • Conjoint Analysis-Based Simulation of a Market Scenario
            • TRD Market Simulation: Share of Preference of Target Product Profiles Included in the Market Scenario
            • TRD Market Simulation: Likelihood to Prescribe Target Product Profiles Included in the Market Scenario
            • TRD Market Simulation: Target Product Profiles Included in the Market Scenario
        • Appendix
          • Key Abbreviations
          • Bibliography

      Author(s): Thomas Cronin

      Since joining DRG in late 2019, Tom has worked on reports focusing on psychiatric and ophthalmologic disorders for the CNS team. His background is in biochemistry and he previously worked in the intellectual property field as a registered Patent Agent. Prior to joining DRG, Tom was an Intellectual Property Manager in a Boston-based biopharmaceutical company focusing on treating metabolic diseases and disorders. He has also worked for several internationally recognized law firms representing corporate and institutional clients in all matters of life science – related intellectual property.


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