A review of the abuse potential assessment of atomoxetine: a nonstimulant medication for attention-deficit/hyperactivity
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REVIEW
A review of the abuse potential assessment of atomoxetine: a nonstimulant medication for attention-deficit/hyperactivity disorder Himanshu P. Upadhyaya & Durisala Desaiah & Kory J. Schuh & Frank P. Bymaster & Mary J. Kallman & David O. Clarke & Todd M. Durell & Paula T. Trzepacz & David O. Calligaro & Eric S. Nisenbaum & Paul J. Emmerson & Leslie M. Schuh & Warren K. Bickel & Albert J. Allen
Received: 15 March 2012 / Accepted: 12 January 2013 / Published online: 9 February 2013 # The Author(s) 2013. This article is published with open access at Springerlink.com
Abstract Rationale Treatment of attention-deficit/hyperactivity disorder (ADHD) has for many years relied on psychostimulants, particularly various formulations of amphetamines and methylphenidate. These are central nervous system stimulants and are scheduled because of their abuse potential. Atomoxetine (atomoxetine hydrochloride; Strattera®) was approved in 2002 for treatment of ADHD, and was the first nonstimulant medication approved for this disorder. It was
H. P. Upadhyaya (*) : D. Desaiah : K. J. Schuh : D. O. Clarke : T. M. Durell : P. T. Trzepacz : D. O. Calligaro : E. S. Nisenbaum : P. J. Emmerson : A. J. Allen Eli Lilly and Company, Indianapolis, IN 46285, USA e-mail: [email protected] H. P. Upadhyaya Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA F. P. Bymaster Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, USA M. J. Kallman Covance Laboratories, Greenfield, IN, USA L. M. Schuh St. Vincent Carmel Hospital Bariatric Center for Excellence, Carmel, IN, USA W. K. Bickel Virginia Tech Carilion Research Institute, Roanoke, VA, USA H. P. Upadhyaya The University of Texas Medical School at Houston, Houston, TX, USA
classified as an unscheduled medication indicating a low potential for abuse. However, the abuse potential of atomoxetine has not been reviewed. Objectives In this article, we review the evidence regarding abuse potential of atomoxetine, a selective inhibitor of the presynaptic norepinephrine transporter, which is unscheduled/unrestricted in all countries where it is approved. Methods Results from receptor binding, in vitro electrophysiology, in vivo microdialysis, preclinical behavioral, and human laboratory studies have been reviewed. Results Atomoxetine has no appreciable affinity for, or action at, central receptors through which drugs of abuse typically act, i.e., dopamine transporters, GABAA receptors, and opioid μ receptors. In behavioral experiments in rodents, atomoxetine does not increase locomotor activity, and in drug discrimination studies, its profile is similar to that of drugs without abuse potential. Atomoxetine does not serve as a reinforcer in monkey self-administration studies, and human laboratory studies suggest that atomoxetine does not induce subjective effects indicative of abuse. Conclusion Neurochemical, preclinical, and early clinical studies predicted and supported a lack of abuse potential of atomoxetine,
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