Fibromyalgia is a chronic condition characterized by pain and tenderness. The primary goal of treatment is to reduce pain, and there are multiple well-established treatment options available, many of which are generic. Even though the majority of the diagnosed fibromyalgia population receives prescription drug treatment, most current therapies suffer from shortcomings in efficacy. The substantial percentage of patients with inadequate pain relief, the need for improved treatment of the secondary symptoms of fibromyalgia (e.g., anxiety, major depressive disorder, fatigue), and other areas with large unmet need (e.g., drugs that restore neuronal function)together pose ample commercial opportunity for new drugs that improve fibromyalgia treatment.

QUESTIONS ANSWERED

  •  What are surveyed rheumatologists’ opinions of the relative performance of select therapies, including Savella/Ixel/Milnaneurax (Allergan/Pierre Fabre/Neuraxpharm), Cymbalta/Xeristar (Eli Lilly/Boehringer Ingelheim), and Lyrica (Pfizer), on key efficacy, safety/tolerability, and convenience of administration attributes?
  • What are the top areas of unmet need and opportunity in fibromyalgia?
  • Based on the responses of surveyed physicians, what level of unmet need exists for key drug performance attributes?
  • What trade-offs in drug price and drug performance across key drug attributes are surveyed rheumatologists willing to make?

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

Primary research: Survey of 60 U.S. and 30 European rheumatologists fielded in January 2019.

Key companies: Allergan, Boehringer Ingelheim, Eli Lilly, Grünenthal, Janssen, Neuraxpharm, Pfizer, Pierre Fabre.

Key drugs: Duloxetine (Cymbalta/Xeristar, generics), gabapentin (Neurontin, generics), pregabalin (Lyrica, generics), milnacipran (Savella/Ixel, generics), tramadol (Ultram/Topalgic/Contramal/Tramal/Tramacet/Zydol, other brands, generics), amitriptyline, and cyclobenzaprine.

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

  • Chronic Pain - Unmet Need - Detailed, Expanded Analysis | Fibromyalgia (US/EU)
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Efficacy
        • Safety and Tolerability
        • Convenience of Administration
      • Rationale for Drug Selection
        • Products for Fibromyalgia
    • Treatment Drivers and Goals
      • Key Findings: Attribute Importance
      • Relative Importance of Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Surveyed Rheumatologists' Prescribing Decisions in Fibromyalgia
      • Importance of Efficacy Attributes to Prescribing Decisions in Fibromyalgia: United States
      • Importance of Efficacy Attributes to Prescribing Decisions in Fibromyalgia: Europe
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Fibromyalgia: United States
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Fibromyalgia: Europe
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in Fibromyalgia: United States
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in Fibromyalgia: 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 Fibromyalgia: United States
      • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Fibromyalgia: Europe
    • Product Performance Against Treatment Drivers and Goals
      • Key Findings
      • Overall Performance of Key Therapies for Fibromyalgia: United States
      • Overall Performance of Key Therapies for Fibromyalgia: Europe
      • Mean Overall Performance of Key Therapies for Fibromyalgia: United States and Europe
      • Relative Performance of Key Therapies for Fibromyalgia Across Select Efficacy Attributes: United States
      • Relative Performance of Key Therapies for Fibromyalgia Across Select Efficacy Attributes: Europe
      • Relative Performance of Key Therapies for Fibromyalgia Across Select Safety and Tolerability Attributes: United States
      • Relative Performance of Key Therapies for Fibromyalgia Across Select Safety and Tolerability Attributes: Europe
      • Relative Performance of Key Therapies for Fibromyalgia Across Select Convenience of Administration Attributes: United States
      • Relative Performance of Key Therapies for Fibromyalgia Across Select Convenience of Administration Attributes: Europe
    • Assessment of Unmet Need
      • Surveyed Rheumatologists’ Satisfaction with the Performance of Key Therapies for Fibromyalgia on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
      • Surveyed Rheumatologists’ Satisfaction with the Performance of Key Therapies for Fibromyalgia on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Fibromyalgia: United States
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Fibromyalgia: Europe
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Fibromyalgia: United States
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Fibromyalgia: Europe
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Fibromyalgia: United States
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Fibromyalgia: Europe
      • Key Findings: Unmet Need in Fibromyalgia and Related Indications
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need in Fibromyalgia and Related Indications: United States
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need in Fibromyalgia and Related Indications: Europe
    • Opportunity Analysis
      • Areas of Opportunity in the Fibromyalgia Market and Emerging Therapy Insights
        • Opportunity: A New Therapy Offering Greater Reduction in Pain Intensity
        • Opportunity: A New Therapy with an Improved Patient Responder Rate and Global Outcomes
    • 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 Fibromyalgia
      • Attribute Importance and Part-Worth Utilities
        • Fibromyalgia Target Product Profile: Attribute Importance
        • Reduction in 11-Point Pain Intensity Score, Placebo-Adjusted
        • % of Patients with ≥ 30% Reduction in Pain Intensity Score, Placebo-Adjusted
        • % of Patients Reporting “Much/Very Much Improved” on the PGIC Scale, Placebo-Adjusted
        • Rate of Discontinuation Due to Adverse Events, Placebo-Adjusted
        • % of Patients Reporting ≥ 7% Weight Gain Over Baseline, Placebo-Adjusted
        • Dosing Frequency
        • Price per Treated Day Relative to Pregabalin (assuming two divided doses per day)
      • Conjoint Analysis-Based Simulations of Market Scenarios
        • Fibromyalgia Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
        • Fibromyalgia Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
        • Fibromyalgia Market Simulations: Target Product Profiles Included in Scenario 1
        • Fibromyalgia Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
        • Fibromyalgia Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
        • Fibromyalgia Market Simulations: Target Product Profiles Included in Scenario 2
    • Appendix
      • Key Abbreviations
      • Bibliography

Author(s): Audreza Das, P.G. Dip.

Audreza Das, P.G. Dip., B.E., is a senior analyst on the CNS/Ophthalmology Disorders team at DRG, part of Clarivate. She has authored content on neuropathic pain, age-related macular degeneration, attention-deficit/hyperactivity disorder, unipolar depression, bipolar disorder, treatment-related depression, postherpetic neuralgia, painful diabetic neuropathy, and migraine. Ms. Das obtained her P.G. Dip. in cancer immunology and biotechnology from the University of Nottingham and a B.E. in biotechnology from the Birla Institute of Technology.


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