Dr. Frank Vocci, Director of NIDA’s Division of Treatment Research and Development, described the steps involved in development and ultimate approval by the Food and Drug Administration. The process requires an enormous investment of time and money—a decade of research and testing, at a cost as high as $500 million—before new medications are available for patients. Accelerating the process without compromising safety at any stage, from basic research to human clinical trials, will also speed up reduction in the terrible toll of disease and death that tobacco exacts each year.

Dr. John Hughes of the University of Vermont suggested that existing psychiatric medications, which have proven effective in treating neurochemical imbalances in the brain, might hold clues for development of medications to treat the neurochemical effects of smoking. One advantage to research that involves existing pharmacotherapies, he said, is that animal studies and extensive human trials have already demonstrated the safety of the medications. Thus, investigations involving approved drugs might eliminate some of the costly and uncertain investment of resources in new compounds.

Dr. Charles Grudzinskas of Georgetown University Medical Center provided an overview of potential medications now in development—FDA Phase I, II, or III trials—by pharmaceutical firms. These “pipeline” medications include nicotine replacement therapies, vaccines, nicotine agonists, MAO inhibitors, and agents that inhibit CYP2A6 metabolism of nicotine.

Dr. Paul Pentel of the Hennepin County Medical Center in Minneapolis, Minnesota, described progress in the development of vaccines, which target nicotine in the blood rather than neurobiological activity in the brain. Vaccines block nicotine from crossing the blood-brain barrier, preventing the drug from reaching the nucleus accumbens, the brain’s pleasure center. By making nicotine less pleasurable, vaccines may represent a treatment to reduce the likelihood of relapse in smokers who are trying to quit. Six potential vaccines have been studied extensively in animals; two are now in Phase I trials.