Painful diabetic neuropathy (PDN), a subset of diabetic neuropathy; affects approximately seven million people in the United States and major European markets. The primary goal of treating PDN is to reduce the severity and prevent worsening of the pain while improving the patient’s QOL. The most frequently prescribed drugs for treating PDN are Lyrica (Pfizer), gabapentin (Pfizer’s Neurontin, generics), duloxetine (Eli Lilly/Boehringer Ingelheim’s Cymbalta/Xeristar, generics), Nucynta ER/Palexia SR/Yantil (Janssen/Depomed/Grünenthal), and Qutenza (Acorda/Grünenthal). The goal of treatment with all of these agents is to provide adequate analgesia to patients, each of whom may respond differently to these therapies. Despite the availability of these agents and an armamentarium of other drugs in the United States and Europe to treat PDN, opportunity remains in the PDN market for new agents that can address existing unmet needs, such as the need for products with more efficacious and safer profiles.

This Unmet Need content provides quantitative insight into U.S. and European neurologists’ perceptions of key treatment drivers and goals in the treatment of PDN and the current level of unmet need in this indication. We analyze the commercial opportunities and how emerging therapies may capitalize on these opportunities.

Questions Answered:

  • What are the treatment drivers and goals for PDN?
  • 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 PDN?
  • What are the prevailing areas of unmet need and opportunity in PDN?
  • What trade-offs across different clinical attributes and price are acceptable to U.S. and European neurologists for a hypothetical new PDN drug?

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

Primary research: Survey of 61 U.S. and 32 European neurologists fielded in December 2016

Key companies: AbbVie, Acorda Therapeutics, Astellas Pharma, Boehringer Ingelheim, Depomed, Eli Lilly, Grünenthal, Janssen, and Pfizer

Key drugs: Amitriptyline, duloxetine, gabapentin, Lyrica, Qutenza, tapentadol ER, and Vicodin

Table of contents

  • Neuropathic Pain - Unmet Need - Detailed Expanded Analysis Painful Diabetic Neuropathy
    • Key Updates
      • December 2017
        • August 2017
          • April 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 PDN
              • Importance of Efficacy Attributes to Prescribing Decisions in PDN: United States
              • Importance of Efficacy Attributes to Prescribing Decisions in PDN: Europe
              • Importance of Safety and Tolerability Attributes to Prescribing Decisions in PDN: United States
              • Importance of Safety and Tolerability Attributes to Prescribing Decisions in PDN: Europe
              • Importance of Convenience of Administration Attributes to Prescribing Decisions in PDN: United States
              • Importance of Convenience of Administration Attributes to Prescribing Decisions in PDN: Europe
            • Stated Versus 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 PDN: United States
              • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in PDN: Europe
          • Product Performance Against Treatment Drivers and Goals
            • Overview
            • Rationale for Drug Selection
              • Products for PDN
            • Current Brand Performance on Key Treatment Drivers and Goals
              • Overall Performance of Key Therapies for PDN: United States
              • Overall Performance of Key Therapies for PDN: Europe
              • Relative Performance of Key Therapies for PDN Across Select Efficacy Attributes: United States
              • Relative Performance of Key Therapies for PDN Across Select Efficacy Attributes: Europe
              • Relative Performance of Key Therapies for PDN Across Select Safety and Tolerability Attributes: United States
              • Relative Performance of Key Therapies for PDN Across Select Safety and Tolerability Attributes: Europe
              • Relative Performance of Key Therapies for PDN Across Select Convenience of Administration Attributes: United States
              • Relative Performance of Key Therapies for PDN Across Select Convenience of Administration Attributes: Europe
          • Assessment of Unmet Need
            • Overview
            • Overall Satisfaction with Current Treatment
              • Surveyed Neurologists’ Satisfaction with the Performance of Key Therapies for PDN on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
              • Surveyed Neurologists’ Satisfaction with the Performance of Key Therapies for PDN on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
            • Physician Rating of Unmet Need in PDN
              • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in PDN: United States
              • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in PDN: Europe
              • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in PDN: United States
              • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in PDN: Europe
              • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in PDN: United States
              • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in PDN: Europe
            • Unmet Need in PDN and Related Indications
              • Surveyed Neurologists' Ascribed Level of Unmet Need in PDN and Related Indications: United States
              • Surveyed Neurologists' Ascribed Level of Unmet Need in PDN and Related Indications: Europe
          • Opportunity Analysis
            • Areas of Opportunity in the PDN Market and Emerging Therapy Insights
              • Opportunity: A New Therapy Offering Improved Reduction in Pain Intensity
              • Opportunity: A New Therapy with a Better Outcome on the Patient Global Impression of Change (PGIC) Score
          • Target Product Profiles
            • Assessing Drug Development Opportunities
            • Target Product Profile Methodology
              • Attributes and Attribute Levels
              • Assigned Prohibitions for the Conjoint Module
            • Attribute Importance and Part-Worth Utilities
              • PDN Target Product Profile: Attribute Importance
              • Reduction in 11-Point Pain Intensity Score
              • % of Patients Achieving a ≥ 50% Reduction in Pain Intensity Score
              • % of Patients Reporting "Much Improved" or "Very Much Improved" on the PGIC Scale
              • % of Patients Reporting ≥ 7% Weight Gain over Baseline
              • Delivery Profile
              • Controlled Substance Restrictions Imposed on Manufacture/Distribution/Prescription
              • Price per Treated Day Relative to Lyrica (assuming three divided doses per day)
            • Conjoint Analysis-Based Simulations of Market Scenarios
              • PDN Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
              • PDN Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
              • PDN Market Simulations: Target Product Profiles Included in Scenario 1
              • PDN Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
              • PDN Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
              • PDN Market Simulations: Target Product Profiles Included in Scenario 2
              • PDN Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 3
              • PDN Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 3
              • PDN Market Simulations: Target Product Profiles Included in Scenario 3
          • Appendix
            • Key Abbreviations
            • Bibliography

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

        Audreza Das is a Senior Analyst in the CNS/Ophthalmology team at Decision Resources Group

        She has authored content across indications, including neuropathic pain, age-related macular degeneration, treatment-related depression, painful diabetic neuropathy, and migraine. Ms. Das has previously worked at Novo Nordisk, as a Market Analyst for European markets. Previous experience at a SME, included developing disease competitive landscapes, covering global conferences etc. Ms. Das received her B.E. degree in Biotechnology from Birla Institute of Technology, a deemed university and her P.G. Diploma in Cancer Immunology & Biotechnology from University of Nottingham.