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Articles   |    
The Diminished Pipeline for Medications to Treat Mental Health and Substance Use Disorders
Peggy L. O'Brien, Ph.D., J.D.; Cindy Parks Thomas, Ph.D.; Dominic Hodgkin, Ph.D.; Katharine R. Levit, B.A.; Tami L. Mark, Ph.D., M.B.A.
Psychiatric Services 2014; doi: 10.1176/appi.ps.201400044
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Dr. O'Brien and Dr. Hodgkin are with the Institute for Behavioral Health and Dr. Thomas is with the Schneider Institute for Health Policy, Heller School of Social Policy and Management, Brandeis University, Waltham, Massachusetts (e-mail: pegmlob@brandeis.edu). Ms. Levit and Dr. Mark are with the Department of Behavioral Health and Quality Research, Truven Health Analytics, Washington, D.C.

Copyright © 2014 by the American Psychiatric Association


Objective  Psychotropic drug development is perceived to be lagging behind other pharmaceutical development, even though there is a need for more effective psychotropic medications. This study examined the state of the current psychotropic drug pipeline and potential barriers to psychotropic drug development.

Methods  The authors scanned the recent academic and “grey” literature to evaluate psychotropic drug development and to identify experts in the fields of psychiatry and substance use disorder treatment and psychotropic drug development. On the basis of that preliminary research, the authors interviewed six experts and analyzed drugs being studied for treatment of major psychiatric disorders in phase III clinical trials.

Results  Interviews and review of clinical trials of drugs in phase III of development confirmed that the psychotropic pipeline is slim and that a majority of the drugs in phase III trials are not very innovative. Among the barriers to development are incentives that encourage firms to focus on incremental innovation rather than take risks on radically new approaches. Other barriers include human brain complexity, failure of animal trials to translate well to human trials, and a drug approval threshold that is perceived as so high that it discourages development.

Conclusions  Drivers of innovation in psychotropic drug development largely parallel those for other drugs, yet crucial distinctions have led to slowing psychotropic development after a period of innovation and growth. Various factors have acted to dry up the pipeline for psychotropic drugs, with expert opinion suggesting that in the near term, this trend is likely to continue.

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Table 1Status of drugs in open or active phase III drug trials for treatment of psychiatric disorders
Table Footer Note

a Some trials were listed in the clinical trials Web site under multiple disorders, such as comorbid alcohol use disorders and PTSD, which is considered an anxiety disorder.

Table Footer Note

b Includes drugs that were studied in combination

Table Footer Note

c Includes drugs that had not yet been approved by the U.S. Food and Drug Administration for any purpose, excluding drugs that are marketed as supplements



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