Review of key trends in the development of new depression drugs across the seven major markets. Also includes detailed analyses of clinical trial design, target product profile, innovative early-stage projects, and future treatment developments.
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
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
Strategic scoping and focus
Update details: January 2012
Datamonitor key findings
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
Lexapro (escitalopram; Forest/Lundbeck)
Target product profile versus current level of attainment
CLINICAL TRIAL DESIGN IN DEPRESSION
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