R&D Trends: Depression - Clinical attrition driven by mature market conditions

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R&D Trends: Depression – Clinical attrition driven by mature market conditions

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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?

OVERVIEWCatalystSummaryEXECUTIVE SUMMARYStrategic scoping and focusUpdate details: January 2012Datamonitor key findingsRelated reportsCLINICAL PIPELINE OVERVIEWOverview of the depression pipelineDatamonitor has identified 46 separate programs in clinical developmentEmerging features of the depression pipelineChanges in pipeline dynamicsCompanies involved in the depression pipelineDiscontinued pipeline drugs in depression54 distinct depression projects have been discontinued since 2010The vast majority of discontinuations happen either during preclinical testing or Phase II studiesNeuropeptide modulators and monoamine reuptake inhibitors head the list of discontinued projectsTARGET PRODUCT PROFILEComparator therapiesLexapro (escitalopram; Forest/Lundbeck)Target product profile versus current level of attainmentCLINICAL TRIAL DESIGN IN DEPRESSIONClinical trialsCommonly used clinical trial endpoints for depressionTypical trial designTrial length is commonly standardized to a duration of just 8 weeks Comparator trials can provide a compelling argument for using one drug ahead of anotherFuture developments in clinical trial designTreatment-resistant depression clinical trial designAdjunctive therapy clinical trial designINNOVATIVE EARLY-STAGE APPROACHESGlutamate receptor modulationNMDA receptor antagonists and partial agonistsMetabotropic glutamate receptor antagonistsTargeting neuropeptides for depressionBackgroundVasopressin receptor antagonistsNeurokinin receptor antagonistsTHE FUTURE OF TREATMENT IN DEPRESSIONSpecific targeting of treatment-resistant patientsA label for treatment-resistant depression will bypass competition with generic first-line antidepressantsTreatment-resistant depression is characterized by a large target population and substantial unmet needBiomarkers for depressionConsiderable variations in treatment outcomes existBiomarkers may have utility in identifying likely responders and improving treatment outcomesThe commercial appeal of reduced R&D spend and a competitive advantage is a bonusBiomarkers in clinical developmentBIBLIOGRAPHYJournal papersWebsitesDatamonitor reportsAPPENDIXContributing expertsConferences attendedReport 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

FIGURESFigure: Depression clinical pipeline, by developmental stage, January 2012Figure: Depression clinical pipeline, by mode of action, January 2012Figure: Products in clinical development for depression, 2007, 2011, and 2012Figure: Modes of action in the depression pipeline, 2007, 2011, and 2012Figure: Depression pipeline, by developmental stage and company type, January 2012Figure: Big Pharma's involvement in the depression pipeline, January 2012Figure: Discontinued drugs formerly in development for depression, by developmental stage, 2010–12Figure: Modes of action of discontinued pipeline drugs and active pipeline drugs in depression, 2010–12Figure: Head-to-head clinical trial of Lexapro (escitalopram; Forest/Lundbeck) versus Celexa (citalopram; Forest/Lundbeck)Figure: Potential timeline for future depression therapiesFigure: Proportion of patients that display treatment-resistant depression (%) in the seven major markets, 2010Figure: BRITE-MD study of the Antidepressant Treatment Response Index as a functional biomarker for depressionCompanies mentioned Commerzbank AG, GlaxoSmithKline Plc, Hutchison 3G UK Limited, Johnson & Johnson, Kewill plc, Telenor ASA

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