Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Case Studies: LAAM, Naltrexone, Clozapine, and Nicorette


The purpose of the case studies is to gain insight into the experiences of companies that are relevant to developing and marketing medications for drug abuse and addiction. Presented below are two in-depth case studies of LAAM (Roxanne), for heroin addiction, and naltrexone (DuPont Merck), for heroin (as Trexan) and alcohol (as ReVia) addiction. In addition, we present two smaller case studies on clozapine (Sandoz), for schizophrenia, and Nicorette (SmithKline Beecham), for smoking addiction. These case studies address the following general topic areas: (1) product history and development timeline; (2) clinical development and product positioning issues; (3) product marketing strategy and sales; (4) policy interaction in product development and distribution (e.g., with HHS, FDA, NIH, and DEA); and (5) likely future of the product.