title: Challenges to medications development in treating alcohol dependence: an international perspective.
abstract: Few medications for treating alcohol dependence exist. Greater partnership is needed between academia and the pharmaceutical industry to develop, licence and market efficacious medications for treating alcohol dependence. Methodologies that span the divide between preclinical and large-scale clinical studies need to be developed in order to provide sufficient information on safety, toleration, drug-interaction profile and efficacy, with which to guide development decisions. Due to the heterogeneous nature of alcohol dependence, the effort of developing an efficacious medication is likely to be enhanced by clearer choices about the characteristics of the population. Careful consideration of potential mechanism of action of the putative therapeutic medication should enable the appropriate choice of drinking endpoint. The pharmaceutical industry in collaboration with academia might need to develop new approaches to determining appropriate treatment endpoints with regulatory bodies. The investment risk to industry should be appraised not only in terms of the rather poor results of previous marketing efforts but with a view to the opportunity to penetrate a potentially enormous and largely untapped market.
authors.affiliation: Department of Molecular and Biomedical Pharmacology, University of Kentucky, Cooper and University Drives, Lexington 40546-0236, USA. jlittlet@uky.edu
authors.forename: John M
authors.initials: JM
authors.lastname: Littleton
authors.forename: Philippe
authors.initials: P
authors.lastname: De Witte
authors.forename: Raye
authors.initials: R
authors.lastname: Litten
authors.forename: Gian Luigi
authors.initials: GL
authors.lastname: Gessa
authors.forename: Rainer
authors.initials: R
authors.lastname: Spanagel
authors.forename: Henry
authors.initials: H
authors.lastname: Kranzler
authors.forename: Philippe
authors.initials: P
authors.lastname: Lehert
authors.forename: Bankole
authors.initials: B
authors.lastname: Johnson
authors.forename: John
authors.initials: J
authors.lastname: Saunders
authors.forename: Mats
authors.initials: M
authors.lastname: Berglund
authors.forename: Adron
authors.initials: A
authors.lastname: Harris
authors.forename: Raymond
authors.initials: R
authors.lastname: Anton
authors.forename: Karl
authors.initials: K
authors.lastname: Mann
mesh_terms: D000437:Alcoholism / Q000188:drug therapy*; D002986:Clinical Trials as Topic / Q000379:methods; D004345:Drug Industry / Q000379:methods*; D006801:Humans; D038622:Internationality