- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
Phase 3 study evaluating Pristiq in paediatric patients with major depressive disorder fails to meet its primary objective
12 June 2015 • Author: Victoria White
Pfizer has reported the top line results from a Phase 3 study which evaluated the efficacy, safety and tolerability of Pristiq® (desvenlafaxine succinate sustained-release formulation) in paediatric patients ages 7 to 17 with Major Depressive Disorder (MDD).
The study did not meet its primary objective to demonstrate superior efficacy of Pristiq compared to placebo.
This is the first completed study of four Phase 3 paediatric trials being conducted as part of a US Food and Drug Administration (FDA) post-marketing commitment under the Paediatric Research Equity Act (PREA).
The study was a randomised, double-blind, placebo-controlled, fluoxetine-referenced study designed to evaluate the efficacy, safety, and tolerability of Pristiq in paediatric outpatients ages 7 to 17 with MDD. The patient population was comprised of children (7-11 years of age) and adolescents (12-17 years of age) and included three treatment arms: Pristiq, fluoxetine and placebo.
Full results from the Pristiq study will be submitted for publication
Efficacy results indicate that both desvenlafaxine succinate sustained-release formulation and the positive control, fluoxetine, were not statistically significantly different from placebo.
There were no new safety signals identified. Adverse events occurring after the start of treatment in the desvenlafaxine succinate sustained-release formulation group were generally consistent with those observed in both the Phase 2a paediatric MDD safety studies and the studies of desvenlafaxine succinate sustained-release formulation-treated adults with MDD.
Full results from the study will be submitted for publication.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Butterworth Laboratories Ltd CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe Kaiser Optical Systems Inc. L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Lonza MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. Peak Scientific ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics