Sleeper Diseases: Forecast and Assessment of Neglected Disease Market Opportunities

Published by: CHI Insight Pharma Reports

Published: Feb. 1, 2006

Table of Contents

Autism: A Developmental Disorder That Is Massively on the Rise

Symptoms, Diagnosis, and Epidemiology

Etiology

Inconclusive Results of Genetic Investigations

Current Drug Treatments and Trials Involving Drugs Approved for Other Indications

Anticonvulsants

Selective Serotonin Reuptake Inhibitors

Atypical Antipsychotics

Cholinesterase Inhibitors

Antioxidants and Antiexcitatory Drugs

Potential New Drugs for Autism and Autistic Spectrum Disorders

Specific Challenges for Drug Development in Autism

Secretin: A Failed Hope

CureMark’s Digestive Enzymes

Oralgam: An Oral Immunoglobulin with Presumed Intestinal Action

RG-2077: Another Potential Immunotherapy

SRX-251

Other Approaches Described in the Patent Literature

The Autism Drug Therapy Market to 2015

A Target Population with a Largely Unpredictable Development

Sales Development To Be Driven by New Drugs

References

Index

Figures and Tables

Figure 1. Key Symptoms of Autism

Figure 2. Incidence of U.S. Autism Cases, 1992 to 2003

Table 1. Drugs Approved for Other Indications That Are Used to Manage or Are in Clinical Trials for Autism

Table 2. Potential New Drugs for Use in Autism

Compulsions, Phobias, Panic Attacks: Disruptive Intrusions of Normal Life

Obsessive-Compulsive Disorder

OCD Etiology

Panic Disorder and Phobias

Current Drug Treatments for OCD, APD, and Social Phobia

Selective Serotonin Reuptake Inhibitors (SSRIs): The Mainstay of Therapy

Other Drug Therapies and Developments Based on Available Drugs

Antidepressant Drug Augmentation for OCD

Few Acceptable Alternatives to SSRIs in Panic Disorder

Anticonvulsants Used Off-Label for Social Phobia

Drug Candidates in Development

At the Beginning, the Model Systems

Few Promising New Drug Candidates in Development

Market Scenarios for OCD, APD, and Social Phobia

The SSRI Era Has Exhausted Its Potential

New Mechanisms Are Needed to Compete with Psychotherapy

A Market Waiting for One More Boost

References

Index

Figures and Tables

Figure 1. Disturbed Neurotransmitter Pathways in OCD

Figure 2. Projected Combined Market for OCD, APD, and SAD, to 2015

Table 1. Symptoms of OCDs, Panic Attacks, and Phobias

Table 2. SSRIs Currently Used in Treatment of OCD, APD, and SAD

Table 3. Drug Candidates in Development for OCD and Panic Disorders

Chronic Fatigue Syndrome and Fibromyalgia: Enigmatic Etiological Models

Chronic Fatigue Syndrome and Fibromyalgia Syndrome: Diagnostic Criteria

Chronic Fatigue Syndrome

Fibromyalgia Syndrome

The Enigma of Etiology

Epidemiology and Economic Implications of Chronic Fatigue Syndrome and Fibromyalgia Syndrome

Incidence and Prevalence

Economic Sequels

Currently Available Drugs under Development for Fibromyalgia Syndrome as Additional Indication

Milnacipran (Ixel; Pierre Fabre Medicament/Cypress Biosciences/Forest Laboratories)

Duloxetine (Eli Lilly’s Cymbalta)

Paroxetine (GlaxoSmithKline’s Paxil CR)

Pregabalin (Pfizer’s Lyrica)

Sodium Oxybate (Gamma-Hydroxybutyrate; Orphan Medical’s Xyrem)

Tropisetron (Novartis’ Navoban)

Pharmacotherapeutic Concepts for the Future

Ampligen (Hemispherx Biopharma, Inc.)

Eplivanserin (sanofi-aventis)

AD-337 (Arakis Ltd.)

Androgen Hormone Therapy (Bentley Pharmaceuticals, Inc.)

Scenarios for the Chronic Fatigue Syndrome and Fibromyalgia Drug Market to 2015

References

Index

Figures and Tables

Figure 1. Location of the “Tender Points” in Fibromyalgia

Figure 2. Projected Growth in Drug Sales for FMS and CFS, to 2015

Table 1. Signs and Symptoms Associated with FMS

Table 2. Marketed Drugs under Study for Label Extension to FMS

Table 3. Pharmacotherapies under Investigation for FMS and CFS

Eating Disorders: Beyond the Obesity Debate

Introduction

Anorexia Nervosa

Binge Eating Disorder

Bulimia Nervosa

Assessment Tools for Eating Disorders

Epidemiology and Psychiatric Comorbidity

Etiology of the Eating Disorders

Current Pharmacotherapeutic Approaches

Selective Serotonin Reuptake Inhibitors for Anorexia and Bulimia

Several Drug Classes Seem Effective in Binge Eating Disorder

Atypical Antipsychotics

New Pharmacologic Approaches to Eating Disorders

Ghrelin, the Major Orexigenic “Brain-Gut Peptide”

Neuropeptide Y

Melanin and Melanocortin-Related Agents

Histamine H3 Receptor Ligands

Serotonin Receptor Ligands

Other Mechanisms under Investigation for Eating Disorders

Scenarios for the Developing Eating Disorder Pharmacotherapy Market

References

Index

Figures and Tables

Figure 1. Synergizing Risk Factors for the Development of Eating Disorders

Figure 2. Schematic Representation of Neuropeptide Circuitries Involved in Appetite Control and Eating Disorders

Figure 3. Projected Market Size in U.S. Millions of Dollars, to 2015

Table 1. Most Frequently Used Assessment Tools for Eating Disorders

Table 2. Medications Currently Used in Treatment of Eating Disorders

Table 3. Experimental Approaches to the Pharmacotherapy of Eating Disorders

Table 4. Estimated Number of U.S. Individuals Meeting Criteria for Eating Disorders and Corresponding Market Size, 2005 to 2015

Restless Legs Syndrome: Much More Than a Nuisance

Symptoms and Sequels

Prevalence and Assessment of Severity

Causes

Current and Potential Future Pharmacotherapies

Ropinirole

Pramipexole

Transdermal Rotigotine

Transdermal Liseride

Cabaser (Cabergoline)

Radafaxine

SEP-0226330

Nondopaminergic Candidate Drugs

Novel Opioids: A Potential Field of Discovery

Projections for the RLS Market to 2015

The Treatment Population and Its Projected Development

Population Aging as a Driver

Renal Disease Not a Significant Modifier

RLS Awareness among Patients and Physicians: The Largest Market Driver

Estimation of the Sales Volume Potential

A Scenario for the RLS Drug Market in 2015

References

Index

Figures and Tables

Figure 1. Possible Pathophysiologic Basis of Restless Legs Syndrome (RLS) and Periodic Limb Movements (PLM)

Figure 2. Recommended Treatment Algorithm for Intermittent, Daily, and Refractory RLS

Figure 3. RLS-Related Drug Sales (Estimates)

Table 1. Summary of Recently Published Cross-Sectional, Population-Based Restless Legs Syndrome/Periodic Limb Movement Disorder Epidemiologic Studies

Table 2. Drugs in Development for RLS Indications

Table 3. Estimated Number of U.S. Individuals with Moderate or Severe RLS as Opposed to the Diagnosed Population, 2005 to 2015

Table 4. Estimated Number of Individuals in the United Kingdom, Germany, France, Spain, and Italy with Moderate or Severe RLS as Opposed to the Diagnosed Population, 2005 to 2015

Abstract

• They are well defined and “real” beyond any reasonable doubt, although their etiology might be unknown or scientists’ understanding of them might be highly incomplete.
• They affect a considerable number of otherwise healthy individuals in ways that significantly compromise their quality of life, social functioning, and professional accomplishments.
• They respond to treatment with currently available medications (or at least some of their constituent aspects do to a limited degree), and novel drugs (frequently based on genetic insights that reveal possible targets) are being investigated on the basis of scientifically defendable working hypotheses.

• Autism: A Developmental Disorder That Is Massively on the Rise
• Compulsions, Phobias, Panic Attacks: Disruptive Intrusions of Normal Life
• Chronic Fatigue Syndrome and Fibromyalgia: Enigmatic Etiological Models
• Eating Disorders: Beyond the Obesity Debate
• Restless Legs Syndrome: Much More Than a Nuisance

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