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Research & Markets: Only Eli Lilly's Symbyax and AstraZeneca's Seroquel have Received FDA Approval for Treatment of Bipolar Depression.


DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c53479) has announced the addition of the Decision Resources, Inc report: Bipolar Disorder bipolar disorder, formerly manic-depressive disorder or manic-depression, severe mental disorder involving manic episodes that are usually accompanied by episodes of depression. : Can Competitive Advantage Be Established in a Challenging Market? to their offering.

A poorly understood, complex disease that involves a number of neurotransmitters Neurotransmitters
Chemicals within the nervous system that transmit information from or between nerve cells.

Mentioned in: Bulimia Nervosa, Impotence, Pain, Withdrawal Syndromes
, 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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 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.

Get the Answers You Need to Shape Your Strategy

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 unipolar /uni·po·lar/ (u?ni-po´ler)
1. having a single pole or process, as a nerve cell.

2. pertaining to mood disorders in which only depressive episodes occur.
 depression or bipolar mania. What strategies does treatment of bipolar depression rely upon? Which classes of antidepressants Antidepressants
Medications prescribed to relieve major depression. Classes of antidepressants include selective serotonin reuptake inhibitors (fluoxetine/Prozac, sertraline/Zoloft), tricyclics (amitriptyline/ Elavil), MAOIs (phenelzine/Nardil), and heterocyclics
 appear to be the most effective for treating bipolar depression?

Several agents have received specific 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 specifically pursuing FDA approval for their BPD agents?

Scope

-- BPD background: Symptoms, pathophysiology pathophysiology /patho·phys·i·ol·o·gy/ (-fiz?e-ol´ah-je) the physiology of disordered function.

path·o·phys·i·ol·o·gy
n.
1.
, and etiology.

-- Treatment options: Current therapies for the four common types of episodes associated with bipolar I Bipolar I is a sub-diagnosis of bipolar disorder. Diagnosis of Bipolar I requires at least one Manic or Mixed episode, but there may be episodes of Hypomania or Major Depression as well. (This diagnosis conforms to the classic concept of manic depressive illness.  disorder and bipolar II bipolar II
n.
See dysphoric hypomania.
 disorder.

-- Market dynamics: Sales growth statistics for BPD-approved agents versus non-BPD-approved agents; sales and prescriptions of antipsychotics Antipsychotics
A class of drugs used to control psychotic symptoms in patients with psychotic disorders such as schizophrenia and delusional disorder. Antipsychotics include risperidone (Risperdal), haloperidol (Haldol), and chlorpromazine (Thorazine).
 and antiepileptics in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. .

-- 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.

Topics Covered

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
This article is an expansion of a section entitled Treatment from within the main article: Bipolar disorder


Bipolar disorder has not currently been cured but it can be managed.
 

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

Companies Mentioned

- Abbott Laboratories Abbott Laboratories (NYSE: ABT) is a diversified pharmaceuticals and health care company. It has over 65,000 employees and operates in 130 countries. The corporate headquarters are in Abbott Park, Illinois, a neighborhood of North Chicago, Illinois.  - 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 or·ga·non or or·ga·num
n. pl. or·ga·nons or or·ga·nums or or·ga·na
1. An organ.

2. A set of principles for use in scientific investigation.



organon

pl. organa [Gr.] organ.
 - Ortho-McNeil - Otsuka Pharmaceutical - Pfizer - Repligen - Sanofi -Aventis - Shire Pharmaceutical - Solvay Pharmaceuticals - Taisho - Titan Pharmaceuticals - Vanda Pharmaceuticals - Wyeth

For more information visit http://www.researchandmarkets.com/reports/c53479.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Apr 5, 2007
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