ANTI-COCAINE DRUG TRIALS WILL BE FORESHORTENED
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.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth