Description
Introduction
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.
Features and benefits
• 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
Highlights
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.
Your key questions answered
• 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?
Table of Contents
Executive Summary
Strategic scoping and focus
Datamonitor key findings
Related reports
OVERVIEW
Catalyst
Summary
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
Late-stage development compounds recently discontinued
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
Corticotropin-releasing factor 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 appropriate patients 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
