This report provides an analysis of the market barriers to the development of pharmacotherapies for cocaine abuse and addiction. The topic of drug addiction continues to raise significant medical, social, and economic public health concerns, and pharmacotherapy offers a means for improving the treatment of drug addiction. Only a handful of medications have been developed and received FDA approval for treatment of opiate addiction during the past 30 years, but these have had limited success and better medications are needed. Further, no pharmacotherapies have been approved for the treatment of cocaine addiction, and, according to a 1995 Institute of Medicine (IOM) report on the development of anti-opiate and anti-cocaine medications, there has been a reluctance on the part of the pharmaceutical industry to enter the field of anti-addiction products because of considerable market disincentives.
The 1995 IOM report found that the major disincentives to pharmaceutical R&D for anti-addiction medications include an inadequate science base on addiction and the prevention of relapse, and an uncertain market environment regarding e.g., treatment financing, lack of trained specialists for treatment of drug addiction, federal and state regulations, market size, pricing issues, societal stigma, liability issues, and difficulties in conducting clinical research.
The purpose of this report is to review and analyze market barriers (both real and perceived) to the development of pharmacotherapies for the treatment of cocaine abuse and addiction. This report provides the Department with information and analyses in the following four areas:
- characteristics of the market for cocaine abuse and addiction pharmacotherapies
- real and perceived market barriers to cocaine pharmacotherapy development
- case studies of the development and marketing of selected pharmacotherapies
- private industry's perception of the readiness of the science base for developing such medications
This report is not intended to analyze or make recommendations concerning any particular government initiatives or other policies that may be under consideration by the Department regarding treatments for cocaine abuse.
Pursuant to the purpose of this project, ASPE contracted with The Lewin Group to:
- conduct a market analysis for a prospective cocaine medication;
- conduct case studies of selected pharmacotherapies (LAAM, naltrexone, clozapine, and Nicorette) through literature reviews and interviews with key individuals involved in the development and marketing of these products;
- conduct interviews with representatives of several private firms (e.g., pharmaceutical companies, venture capital firms) to determine industry's views on market barriers (including the readiness of the science base for a pharmacotherapy for cocaine abuse and addiction).
The present document is organized as follows. First, it provides a market analysis from the perspective of a private firm considering an investment in the development of a cocaine pharmacotherapy. This includes discussions of the relationships among such factors as market size, price, and revenues as they relate to corporate decision making. Second, the report describes five hypothetical scenarios of company decision making regarding investing in new drug development for treating cocaine addiction. These scenarios help to illustrate how various market factors and financial parameters may affect drug development decisions. Third, the report documents the case experiences of pharmaceutical firms that have developed pharmacotherapies for substance abuse and addiction, e.g., LAAM and naltrexone. Also provided are case study reports of two non-substance abuse drugs, clozapine and Nicorette, in order to draw lessons from other disease areas that may be applicable to future development in the cocaine area. Finally, the report addresses market barriers to the development of cocaine pharmacotherapies, including readiness of science base, as described by scientific, marketing, and other executive-level representatives of several key private sector stakeholders (e.g., pharmaceutical companies, venture capital firms).