躁鬱症：統合失調症的藥劑開發對小規模躁鬱症生產線趨勢的影響 是由出版商Datamonitor在2011年04月所出版的。
這份英文市場調查報告書包含Pages: 75 價格從美金3800起跳。
過去5年間、躁鬱症治療藥的研究開發有各種成功的案例。透過臨床生產線所上市的5種藥劑、中斷4種後期候補藥。此外所認定的藥劑中的4種擴大適應範圍中。Alexza的AZ-004（loxapine）是目前市場中最常用的藥劑。
本報告書內容包括:躁鬱症後期及早期藥劑生產線的趨勢分析、未來的治療藥介紹、臨床試驗設計的概要等彙整、內容綱要摘記如下:
概要
實施摘要
臨床生產線概要
- 躁鬱症臨床生產線的概要
- 最近所中止的後期開發化合物
標的產品介紹
- Seroquel XR
- 標的產品介紹和目前的達成等級
躁鬱症的臨床試驗設計
- 臨床試驗
- 針對躁鬱症臨床試驗實施的FDA導覽的不充足
- EMA為主要的躁鬱症適應推選之臨床試驗設計
- 躁鬱症的一般性臨床試驗設計
- 躁鬱症的相關一般所用的評價項目
- 其他的評價項目
- 躁鬱症的臨床試驗實施的主要課題
- 臨床試驗設計的未來性發展
- 躁鬱症特異性回歸對策的開發
- 臨床試驗的兒童及成人躁鬱症患者的介入
創新的早期階段對策
躁鬱症的未來治療方法
- 大規模研究計畫對所有患者的治療回歸改善為目的的進行中
- 個別化醫療
- 躁鬱症的相關認識障礙的治療
參考資訊
附錄
圖表
Abstract
Introduction
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
Features and benefits
• 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.
Highlights
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.
Your key questions answered
• 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?
Table of Contents
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
