The four case studies have several elements in common, particularly with regard to the target patient population. For example, three of the four drugs involve treatment for substance abuse including LAAM and naltrexone for heroin addiction, naltrexone for alcoholism, and Nicorette for smoking. Clozapine was included in this study because the market for antipsychotic drugs shares certain characteristics with the market for pharmacotherapies for drug addiction including: 1) small market size, 2) treatment funding primarily through public sources, 3) and some patients who need help caring for themselves and complying with medication. The four patient populations represented in the case studies serve as highly relevant examples of some of the barriers that may exist in the development of pharmacotherapies for cocaine addiction.
Although each population shares several important characteristics, the condition of each population is viewed differently by outside populations. Differences in the markets for these drugs include the levels of federal funding provided for clinical trials, addictive properties of the drug, and treatment delivery system. As a result of these differences, each case study provides key lessons about the barriers to the development of pharmacotherapies (Figure 22 below).
|Case Study Drug||Key Market Lesson|
|LAAM||Existing delivery system via methadone maintenance clinics created significant market barriers.|
|Naltrexone||Despite excellent pharmacological properties, poor patient compliance and failure to gain acceptance by providers and payors severely limited market penetration.|
|Clozapine||High cost of treatment due to required weekly patient monitoring severely limited market penetration.|
|Nicorette||Fewest distribution barriers and over-the-counter approval boosted sales and led to an influx of competing products.|
As mentioned above, the government played a key role in the development of three of the four case study drugs by lowering some of the market barriers, particularly by funding clinical trials. These strategies are summarized in Figure 23 (below), and more detail is provided below.