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Executive Summary

ANTI-COCAINE DRUG TRIALS WILL BE FORESHORTENED by the public clamour for any agent that "really works" in early clinical trials, FDA Pilot Drug Evaluation Staff Medical Officer Curtis Wright, MD, predicted Nov. 29 at a joint Pharmaceutical Manufacturers Association/FDA/Alcohol , Drug Abuse and Mental Health Administration conference on "Opportunities in the Development of Medications for Treating Drug Dependence and Abuse." Drawing from the lessons that FDA has learned about drug development in the AIDS area, Wright said that the sponsor of an anti-cocaine compound and FDA "won't have the luxury of nice, long, lingering, extensive Phase II and Phase III trials." Wright anticipates that manufacturers of future anti-abuse drugs "are going to have to rely a lot more on experimental studies [and] studies in a small number of closely followed patients." Firms with compounds ready for first clinicals, Wright said, will already have to have a good picture of how the medication works and the plan for treatment. "You can't take a drug in the area and troll for an indication," he declared. Instead, Wright suggested including in the IND information on how the drug is metabolized, dosage, kinetics and "all that stuff that some companies don't do until Phase III." FDA Center for Drug Evaluation and Research Director Carl Peck, MD, expressed interest in the development of carbamazepine for treating cocaine addiction. "I want to see [carbamazepine] move," Peck told the PMA/ADMHA/FDA meeting, "because I want to see some data" on the substance for treating cocaine addiction. The drug, Ciba-Geigy's anti-convulsant Tegretol, is the subject of two National Institute on Drug Abuse (NIDA) trials for cocaine craving. Carbamazepine is one of 12 drugs under investigation for the treatment of cocaine dependency at NIDA's Addiction Research Center in Baltimore. FDAer Wright maintained that "successful" trials for INDs hinge on several basic measurements including: a validated subjective measure such as an internal placebo control, a physiologic or biochemical measure and a behavioral measure. Data file standards also would render review easier, he indicated, by facilitating data audits and the collection of missing data.

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