R&D Trends: Depression - Clinical attrition driven by mature market conditions
NEW YORK, March 22, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
R&D Trends: Depression – Clinical attrition driven by mature market conditions
http://www.reportlinker.com/p0799259/RD-Trends-Depression-–-Clinical-attrition-driven-by-mature-market-conditions.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology
Several drugs have progressed through the pipeline for depression in recent years, including Pristiq (desvenlafaxine; Pfizer), Oleptro (trazodone extended release; Labopharm), and Viibryd (Forest) in the US, and Valdoxan (agomelatine; Servier/Novartis) in the EU. Despite the heightened competition within the marketplace, an abundance of drugs remain in the pipeline.Understand key dynamics in the R&D pipeline for new depression therapies Benchmark novel and existing therapies using the target product profile identified by Datamonitor Support R&D decision making by evaluating antidepressant clinical trial designs that have set a precedent Evaluate the most promising new pharmacological targets in early-stage development Access Datamonitor's prediction of how the treatment landscape may change in the next 20 years There are 46 separate programs across all stages of clinical development for depression, down from 66 in 2007 with a notably high attrition of early-stage projects. Reasons for this include promising new targets failing to yield an effective antidepressant, and big players such as GlaxoSmithKline switching its research focus.Although depleted, the early-stage pipeline still has the potential to change current treatment algorithms, which are dominated by monoamine reuptake inhibitors. Popular approaches include glutamate and neuropeptide receptor modulation. Datamonitor sees the future of treatment in depression as the specific targeting of treatment-resistant patients.Clinical trial design in depression is largely standardized. Although not required, head-to-head trials may allow for a more favorable label and explicit marketing claims. Datamonitor believes that future trials will be designed for regulatory approval in patients with treatment-resistant depression, or for use as an add-on to existing therapies.What are the key trends in the depression pipeline?What is the clinical gold standard and how do new candidates have to compare to this to successfully penetrate the market?How will new antidepressant treatments evolve in the next 20 years?
OVERVIEW
Catalyst
Summary
EXECUTIVE SUMMARY
Strategic scoping and focus
Update details: January 2012
Datamonitor key findings
Related reports
CLINICAL PIPELINE OVERVIEW
Overview of the depression pipeline
Datamonitor has identified 46 separate programs in clinical development
Emerging features of the depression pipeline
Changes in pipeline dynamics
Companies involved in the depression pipeline
Discontinued pipeline drugs in depression
54 distinct depression projects have been discontinued since 2010
The vast majority of discontinuations happen either during preclinical testing or Phase II studies
Neuropeptide modulators and monoamine reuptake inhibitors head the list of discontinued projects
TARGET PRODUCT PROFILE
Comparator therapies
Lexapro (escitalopram; Forest/Lundbeck)
Target product profile versus current level of attainment
CLINICAL TRIAL DESIGN IN DEPRESSION
Clinical trials
Commonly used clinical trial endpoints for depression
Typical trial design
Trial length is commonly standardized to a duration of just 8 weeks
Comparator trials can provide a compelling argument for using one drug ahead of another
Future developments in clinical trial design
Treatment-resistant depression clinical trial design
Adjunctive therapy clinical trial design
INNOVATIVE EARLY-STAGE APPROACHES
Glutamate receptor modulation
NMDA receptor antagonists and partial agonists
Metabotropic glutamate receptor antagonists
Targeting neuropeptides for depression
Background
Vasopressin receptor antagonists
Neurokinin receptor antagonists
THE FUTURE OF TREATMENT IN DEPRESSION
Specific targeting of treatment-resistant patients
A label for treatment-resistant depression will bypass competition with generic first-line antidepressants
Treatment-resistant depression is characterized by a large target population and substantial unmet need
Biomarkers for depression
Considerable variations in treatment outcomes exist
Biomarkers may have utility in identifying likely responders and improving treatment outcomes
The commercial appeal of reduced R&D spend and a competitive advantage is a bonus
Biomarkers in clinical development
BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports
APPENDIX
Contributing experts
Conferences attended
Report methodology
TABLES
Table: Products in clinical development for depression, January 2012
Table: Depression clinical pipeline, by mode of action and development stage, January 2012
Table: Discontinued pipeline drugs in depression, 2010–12
Table: Discontinued drugs formerly in development for depression, by mode of action and developmental stage, 2010–12
Table: Lexapro (escitalopram; Forest/Lundbeck) – drug profile in depression, 2012
Table: Defining the gold standard for depression: key clinical trial results for Lexapro
Table: Target product profile in major depressive disorder, 2012
Table: Comparison between the HAM-D and MADRS rating scales for depression
Table: Typical Phase III clinical trial design in major depressive disorder
Table: Key facts: Lexapro (escitalopram; Forest/Lundbeck) versus Cymbalta (duloxetine; Eli Lilly) comparator trial in major depressive disorder
Table: Key facts: Symbyax (fluoxetine and olanzapine; Eli Lilly) pivotal Phase III clinical trial
Table: Key facts: Abilify (aripiprazole; Bristol-Myers Squibb/Otsuka) pivotal Phase III clinical trial
Table: Most promising innovative therapeutic approaches in depression, January 2012
FIGURES
Figure: Depression clinical pipeline, by developmental stage, January 2012
Figure: Depression clinical pipeline, by mode of action, January 2012
Figure: Products in clinical development for depression, 2007, 2011, and 2012
Figure: Modes of action in the depression pipeline, 2007, 2011, and 2012
Figure: Depression pipeline, by developmental stage and company type, January 2012
Figure: Big Pharma's involvement in the depression pipeline, January 2012
Figure: Discontinued drugs formerly in development for depression, by developmental stage, 2010–12
Figure: Modes of action of discontinued pipeline drugs and active pipeline drugs in depression, 2010–12
Figure: Head-to-head clinical trial of Lexapro (escitalopram; Forest/Lundbeck) versus Celexa (citalopram; Forest/Lundbeck)
Figure: Potential timeline for future depression therapies
Figure: Proportion of patients that display treatment-resistant depression (%) in the seven major markets, 2010
Figure: BRITE-MD study of the Antidepressant Treatment Response Index as a functional biomarker for depression
Companies mentioned
Commerzbank AG, GlaxoSmithKline Plc, Hutchison 3G UK Limited, Johnson & Johnson, Kewill plc, Telenor ASA
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Pathology Industry: R&D Trends: Depression – Clinical attrition driven by mature market conditions
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Nicolas Bombourg
Reportlinker
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