The failure of anxiolytic therapies in early clinical trials: What needs to be done
Document Type
Article
Publication Date
4-1-2015
Abstract
Introduction: Anxiety spectrum disorders (ASDs) are highly prevalent psychiatric illnesses that affect millions of people worldwide. Strongly associated with stress, common ASDs include generalized anxiety disorder, panic, social anxiety, phobias and drug-abuse-related anxiety. In addition to ASDs, several other prevalent psychiatric illnesses represent trauma/stressor-related disorders, such as post-traumatic stress disorder and acute stress disorder. Anxiolytic drugs, commonly prescribed to treat ASDs and trauma/stressor-related disorders, form a highly heterogenous group, modulating multiple neurotransmitters and physiological mechanisms. However, overt individual differences in efficacy and the potential for serious side-effects (including addiction and drug interaction) indicate a need for further drug development. Yet, over the past 50 years, there has been relatively little progress in the development of novel anxiolytic medications, especially when promising candidate drugs often fail in early clinical trials.Areas covered: Herein, the authors present recommendations of the Task Force on Anxiolytic Drugs of the International Stress and Behavior Society on how to improve anxiolytic drug discovery. These recommendations cover a wide spectrum of aspects, ranging from methodological improvements to conceptual insights and innovation.Expert opinion: In order to improve the success of anxiolytic drugs in early clinical trials, the goals of preclinical trials may need to be adjusted from a clinical perspective and better synchronized with those of clinical studies. Indeed, it is important to realize that the strategic goals and approaches must be similar if we want to have a smoother transition between phases. ©2015 Informa UK, Ltd.
DOI
10.1517/13543784.2015.1019063
First Page
543
Last Page
556
Volume
24
Issue
4
Publication Title
Expert Opinion on Investigational Drugs
ISSN
13543784
Recommended Citation
Stewart, A. M., Nguyen, M., Poudel, M. K., Warnick, J. E., Echevarria, D. J., Beaton, E. A., Song, C., & Kalueff, A. V. (2015). The failure of anxiolytic therapies in early clinical trials: what needs to be done. Expert Opinion on Investigational Drugs, 24(4), 543–556. https://doi.org/10.1517/13543784.2015.1019063