This column begins a new series on central nervous system (CNS) drug development. This series will review developments up to the present day and end with a forward-looking perspective on what to expect over the next 10–20 years. The goal of this series is to explain to practicing clinicians how drugs are developed and why CNS drug development is at an important juncture involving both significant challenges and opportunities. This column (Part 1) reviews the history of CNS drug development from the period before written history through the golden era (i.e., late 1940s–early 1960s) in which the first modern medications for anxiety, bipolar, depressive, and psychotic disorders were discovered by chance. It also describes the early era of rational drug development in which other agents (e.g., thioridazine, fluphenazine, haloperidol, imipramine) were developed based on those first agents. The blueprint laid down for development of antibiotics is reviewed in relation to its impact on CNS drug development. The impact of the blockbuster business model and modern marketing/sales approaches on CNS drug development is also discussed.
Professor, Department of Psychiatry, University of Kansas School of Medicine-Wichita, and Chief Science Officer and Medical Director, Clinical Research Institute, Wichita, Kansas. He has more than 30 years of drug development research experience at all levels (i.e., preclinical through Phase IV) and has been a principal investigator on over 300 clinical trials including every antidepressant marketed in the United States over the last 25 years. Dr. Preskorn maintains a website at <www.preskorn.com> where readers can access previous columns and other publications
Disclosure statement: Dr. Preskorn, as chief science officer of the Clinical Research Institute, Wichita, KS, and, in many cases, as principal investigator, has received grants/research support from or has served as a consultant or on the advisory board for the following entities: Abbott, Allergan, Amylin, AstraZeneca, Biovail, Boehringer-Ingelheim, Covidien, Cyberonics, Dainippon Sumitomo, Eli Lilly, EnVivo, Evotec, GlaxoSmithKline, Link Medicine, Labopharm, Lundbeck, Pfizer, PsychoGenics, Psylin Neurosciences, Rules-Based Medicine, Takeda, Targacept, Transcept, University of North Carolina at Chapel Hill, and Wyeth.
Material in this column is adapted from Chapter 1, “History of CNS drug development” by Sheldon H. Preskorn, M.D., in Kalali A, ed. Essential CNS Drug Development. Cambridge University Press, in press.