双極性障害

Abstract

Introduction

A poorly understood, complex disease that involves a number of neurotransmitters, bipolar disorder presents several challenges for pharmaceutical companies seeking to develop new treatments. While lithium and several antiepileptic and antipsychotic agents are currently used to treat either manic or mixed episodes of BPD, only Eli Lilly’s Symbyax and AstraZeneca’s Seroquel have received FDA approval for treatment of bipolar depression. The numerous unmet therapeutic needs resulting from the incomplete understanding of BPD create significant opportunities within the competitive BPD market.

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Bipolar disorder represents a market with significant opportunity, but few drug companies are actively developing new agents. What obstacles are currently deterring companies from entering the BPD market? What challenges need to be addressed, and what therapeutic needs remain unmet?

The treatment of depression associated with BPD has not been as extensively studied as the treatment of either unipolar depression or bipolar mania. What strategies does treatment of bipolar depression rely upon? Which classes of antidepressants appear to be the most effective for treating bipolar depression?

Several agents have received specifi c approval for treating BPD; other agents are commonly used off-label. Which agents are most frequently used as off-label treatments for BPD? What competitive advantages, if any, does FDA approval provide? Which companies are specifi cally pursuing FDA approval for their BPD agents?

Scope

• BPD background: Symptoms, pathophysiology, and etiology.
• Treatment options: Current therapies for the four common types of episodes associated with bipolar I disorder and bipolar II disorder.
• Market dynamics: Sales growth statistics for BPD-approved agents versus non-BPD-approved agents; sales and prescriptions of antipsychotics and antiepileptics in the United States.
• Emerging therapies: Antipsychotics and sodium- and calcium-channel blockers currently in development, along with novel approaches.
• Market outlook: Limitations of current BPD agents; challenges still remaining; and the likelihood that any one agent will dominate the BPD market.

Companies Mentioned in This Spectrum Report

• Abbott Laboratories
• AstraZeneca
• Bristol-Myers Squibb
• Dainippon
• D-Pharm
• Eli Lilly
• Forest Laboratories
• Gedeon Richter
• GlaxoSmithKline
• Hoechst Marion Roussel
• Janssen
• Janssen-Cilag International
• Johnson & Johnson
• Kyowa Hakko
• H. Lundbeck
• Marinus Pharmaceuticals
• McNeil
• Memory Pharmaceuticals
• Novartis
• Organon
• Ortho-McNeil
• Otsuka Pharmaceutical
• Pfi zer
• Repligen
• Sanofi -Aventis
• Shire Pharmaceutical
• Solvay Pharmaceuticals
• Taisho
• Titan Pharmaceuticals
• Vanda Pharmaceuticals
• Wyeth

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Introduction
• Overview of Bipolar Disorder
  • Symptoms, Pathophysiology, and Etiology
  • Types of Bipolar Disorder
  • Diagnosis, Epidemiology, and Impact of Bipolar Disorder
• Current Pharmacological Therapies for Bipolar Disorder
  • Lithium
  • Antiepileptic Agents
  • Antipsychotic Agents
  • Antidepressants
• Does Approval Aid Adoption?
• Emerging Therapies for Treatment of Bipolar Disorder
  • Emerging Antipsychotic Agents
    • Janssen’s Invega Extended-Release Tablets
    • Organon’s Asenapine
    • Solvay’s/Wyeth’s/Lundbeck’s Bifeprunox
    • Vanda Pharmaceuticals’ Iloperidone
  • Sodium- and Calcium-Channel Modulators in Development for Bipolar Disorder
    • Novartis’s Licarbazepine (LIC-477)
    • Memory Pharmaceuticals’ MEM-1003
  • Novel Approaches to the Treatment of Bipolar Disorder
• Outlook for the Bipolar Disorder Market

Tables:

• 1. Agents Commonly Used to Treat Bipolar Disorder, 2006
• 2. Emerging Agents for the Treatment of Bipolar Disorder
• 3. Sales of Leading Agents to Treat Bipolar Disorder, 2006

Figures:

• 1. Prevalent Cases of Bipolar Disorder by Type in the Major Markets, 2006
• 2. U.S. Sales of Antipsychotics Used in the Treatment of Bipolar Disorder
• 3. U.S. Prescriptions of Antipsychotics Used in the Treatment of Bipolar Disorder
• 4. U.S. Sales of Antiepileptics Used in the Treatment of Bipolar Disorder
• 5. U.S. Prescriptions of Antiepileptics Used in the Treatment of Bipolar Disorder
• 6. Regional Shares of Bipolar Disorder Treatment Sales in the Major Markets, 2006