TY - JOUR
T1 - Challenges to medications development in treating alcohol dependence
T2 - An international perspective
AU - Littleton, John M.
AU - De Witte, Philippe
AU - Litten, Raye
AU - Gessa, Gian Luigi
AU - Spanagel, Rainer
AU - Kranzler, Henry
AU - Lehert, Philippe
AU - Johnson, Bankole
AU - Saunders, John
AU - Berglund, Mats
AU - Harris, Adron
AU - Anton, Raymond
AU - Mann, Karl
PY - 2004/7
Y1 - 2004/7
N2 - 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.
AB - 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.
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U2 - 10.1093/alcalc/agh067
DO - 10.1093/alcalc/agh067
M3 - Article
C2 - 15208155
AN - SCOPUS:3242762314
SN - 0735-0414
VL - 39
SP - 271
EP - 275
JO - Alcohol and Alcoholism
JF - Alcohol and Alcoholism
IS - 4
ER -