Reportlinker Adds R&D Trends: Bipolar Disorders - Developments in Schizophrenia Dictate Trends in Diminutive Bipolar Disorders Pipeline

NEW YORK, April 26, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

R&D Trends: Bipolar Disorders - Developments in schizophrenia dictate trends in diminutive bipolar disorders pipeline

http://www.reportlinker.com/p0484878/RD-Trends-Bipolar-Disorders---Developments-in-schizophrenia-dictate-trends-in-diminutive-bipolar-disorders-pipeline.html

For the past 5 years R&D for new bipolar disorders drugs has been met with mixed success; while five drugs have progressed through the clinical pipeline and entered the market, four late-stage candidates have been discontinued. For four of the approved products, bipolar disorders represented an indication expansion. Alexza's AZ-004 (loxapine) is currently the closest pipeline candidate to market Analysis of key trends in the late- and early-stage drug pipeline for bipolar disorders. Identification of the target product profile for future bipolar disorders treatments. Summary of clinical trial design in bipolar disorders including exploration of how the design of clinical trials may develop in the future. Exploration of the future treatment in bipolar disorders including personalized medicine and treatment of cognitive impairment. The bipolar disorders pipeline is sparse relative to other psychiatric markets. The diminutive size of the pipeline relative to the depression and schizophrenia pipelines indicates that bipolar disorders are considered less commercially attractive. The limited number of products in development reflects the well-established trend for developers of atypical antipsychotics to seek bipolar disorders as a secondary indication to schizophrenia. However, the time lag between an antipsychotic gaining approval in schizophrenia then bipolar disorders has narrowed in recent years. In the long term, ongoing research is expected to lead to personalized treatment of bipolar disorders. In particular, biomarker research has the potential to predict treatment response in patients. In addition, it is expected that research in schizophrenia may

inform development of cognitive treatments in bipolar disorders. How many drugs are in clinical development for the treatment of bipolar disorders? How does this compare to other psychiatric indications? Is bipolar depression or bipolar mania the most commonly investigated bipolar disorder indication in clinical trials? How is the treatment of bipolar disorders likely to evolve over the next 10 to 20 years? Since 2006, what proportion of late-stage bipolar disorder candidates have progressed through clinical development or been discontinued?

Executive Summary

Strategic scoping and focus

Datamonitor key findings

Related reports

OVERVIEW

Catalyst

Summary

CLINICAL PIPELINE OVERVIEW

Overview of the bipolar disorders clinical pipeline

The bipolar disorders pipeline is small, comprising just 12 candidates in clinical development

Emerging features of the bipolar disorders pipeline

Companies involved in the bipolar disorders clinical pipeline

Late-stage development compounds recently discontinued

Four candidates in the late-stage bipolar disorders pipeline have been discontinued since 2006

TARGET PRODUCT PROFILE

Seroquel XR (quetiapine extended release; AstraZeneca)

Clinical trial data for Seroquel XR

Target product profile versus current level of attainment

CLINICAL TRIAL DESIGN IN BIPOLAR DISODERS

Clinical trials

FDA guidance on the conduct of clinical trials in bipolar disorders is lacking

EMA provides recommendations for clinical trial design in each of the main bipolar disorders indications

Typical trial design in bipolar disorders

Commonly used clinical trial endpoints for bipolar disorders

Other clinical trial endpoints

Key challenges in the conduct of clinical trials in bipolar disorders

Future developments in clinical trial design

Development of bipolar disorders-specific outcome measures for cognition

Involvement of pediatric and adolescent patients with bipolar disorders in clinical trials

INNOVATIVE EARLY-STAGE APPROACHES

Evidence of innovation in the current bipolar disorders pipeline is lacking

The mechanism of action of several early-stage candidates is unknown at this stage

There exists a need to develop novel medications for the treatment of bipolar disorders

THE FUTURE OF TREATMENT IN BIPOLAR DISORDERS

Large-scale research program seeks to improve treatment outcomes for all patients

Current treatment guidelines report several gaps in our understanding of treatment of bipolar disorder

Data from STEP-BP study have the potential to inform optimal use of existing treatments, although key opinion leaders are not convinced

Personalized medicine

Biomarkers may have utility in predicting treatment response in patients with bipolar disorder

Funding from the NIH will stimulate greater research into the pharmacogenomics of bipolar disorders

Treatment of cognitive impairment associated with bipolar disorders

The presence of cognitive impairment in bipolar disorder patients is increasingly recognized

Research in schizophrenia is likely to inform development of cognitive treatments in bipolar disorders

BIBLIOGRAPHY

Journal papers

Websites

Datamonitor reports

APPENDIX

Contributing experts

Conferences attended

Report methodology

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Nicolas Bombourg
Reportlinker
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