The purpose of this section is to characterize private industry's views on market barriers to anti-addiction pharmacotherapy development. The 1995 IOM report, Development of Medications for the Treatment of Opiate and Cocaine Addictions, identified numerous market obstacles that appear to hamper private sector investment in anti-addiction medication development, e.g., market size, development costs, regulatory requirements for approval, and social attitudes about drug abuse (see Figure 35). This section pulls together industry views on these and other market barriers to pharmacotherapies for cocaine abuse and addiction with the objective of identifying barriers with the greatest impact on industry investment decisions. Additional information gathered for this section provides insights into estimating the relative import of various market barriers, including those considered to be "make-or-break" or otherwise critical barriers, and of the feasibility of surmounting them under current circumstances.
Figure 35: Market Obstacles & Creating Incentive
Source: IOM, Development of Medications for the Treatment of Opiate and Cocaine Addictions, 1995.
This section contains information from four sources: a) interviews with executives from five private firms (three pharmaceutical and two venture capital firms); b) the market analysis for a prospective cocaine medication; and c) scenarios of company decisionmaking; and d) case study reports of LAAM, naltrexone, clozapine, and Nicorette. The case study reports, market analysis, and scenarios of company decisionmaking provide information about the market potential for cocaine medications and lessons on development and marketing from previously developed pharmacotherapies.
The interviews with executives of private firms helped to identify the barriers to industry development of medications for cocaine abuse and addiction. It is important to note that the small sample of firms precludes either a representative study or assurance that all possible barriers have been identified. Instead, the primary goal of the interviews with the executives of private firms was to better understand the relative significance of barriers to this market.
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Industry Evaluation of New Drug Investment Opportunities
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In order to provide context for the market environment and background for understanding the market barriers from industry's perspective, this section summarizes pharmaceutical and venture capital firms' approaches to the evaluation of new drug investments.
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Industry Perception of Market Barriers
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Some of the market barriers identified in the 1995 IOM report were confirmed through the interviews with private firms and case studies conducted for this effort. Figure 36 summarizes the market barriers that were confirmed (in full or in part) and not confirmed during this study. (As noted above, the number of interviews and case studies was limited by the scope of this study.) Although no new general types of market barriers were identified during this project, certain ones were elaborated or described in a more contemporary context.
Figure 36: Perceived Market Barriers in 1995 IOM Report Market Barrier from IOM Report Confirmed Not Confirmed Notes Uncertain market environment ✓ Discovery Limited number of researchers focusing on drug abuse ✓ Lack of well-characterized animal models of cocaine addiction ✓ Limited basic science knowledge of addiction, craving, and relapse ✓ File IND Clinical Studies DEA regulations ✓ Complications of concomitant illness and polydrug abuse ✓ Patient population perceived as difficult to study ✓ Efficacy outcomes difficult to define or measure ✓ Few clinical investigators ✓ File NDA Length of FDA approval process ✓ Other Approval State rescheduling ✓ Varied state / local approval processes ✓ DEA review time ✓ Marketing Varied state and local regulations ✓ Lack of traditional marketing to physicians ✓ Pricing clause in DHHS CRADAs ✓ NIH recently removed reasonable pricing clause from CRADAs Small foreign market ✓ Treatment System Limited number of narcotic treatment programs ✓ Stigma of drug-abuse ✓ Bias by some treatment providers against pharmacologic treatments ✓ Varied state / local treatment regulations and financing mechanisms ✓ Uncertain treatment financing ✓ Adapted from: IOM, Development of Medications for the Treatment of Opiate and Cocaine Addictions, 1995. Two types of market barriers emerged from our report. Critical barriers are those that must be surmounted in order for pharmaceutical firms to regard as feasible the prospects for developing cocaine addiction medications that will be financially successful. Non-critical market barriers are those that, if lowered or eliminated, may enhance (though perhaps only marginally) the financial outlook for developing cocaine addiction medications only if the critical barriers are also lowered. That is, without lowering the critical barriers, lowering the non-critical ones would be unlikely to transform an unattractive market into an attractive one.
Among the diverse market barriers perceived by the industry, three emerged as critical in this study, i.e., that would have to be lowered or eliminated in order to begin to make new drug development attractive to pharmaceutical companies:
- Small and uncertain market for cocaine addiction and abuse pharmacotherapy
- A substance abuse treatment system that limits access to this market
- Limited and uncertain payment for treatment
The beginning of the following section briefly describes private industry's views on the strength and importance of these three critical market barriers. The remainder of the section describes non-critical market barriers relative to the process of drug development and marketing.
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Industry Perception of Science Base Readiness
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There was a divergence of opinion among the pharmaceutical company interviewees about the readiness of the science base for cocaine pharmacotherapies. Representatives of two companies expressed skepticism about the readiness of the science base. One representative indicated that current limitations stem from a lack of understanding regarding the biological and genetic basis of addiction. The interviewee contended that, in contrast to the situation for Parkinson's disease, researchers have been unable to implicate the genetic abnormalities underlying addiction, and that the science base for cocaine abuse and addiction is "not close." This interviewee regarded the existing cocaine pharmacotherapies as "half-way technologies." Furthermore, scientists from the same company judged that the probability of a scientific breakthrough in the area of cocaine abuse and addiction in the near future is very low.
Representatives of another pharmaceutical company indicated that a financially successful cocaine medication needed to demonstrate long-term efficacy, but reported that the current science base for achieving long-term efficacy is "very weak." In contrast, representatives of another pharmaceutical company indicated strongly that the science base is ready, and consequently that the science base is no longer a market barrier to development of cocaine pharmacotherapies. This company reported that it had successfully identified several drug candidates that exhibited cocaine blocking activities in both in vivo and in vitro models.
Scientific executives from one company who questioned the science base did suggest that there are opportunities for existing and potential products to be used as effective adjuncts to cocaine abuse therapy. For example, existing drugs for anxiety could help manage symptoms associated with withdrawal.
The views cited in this study concerning the readiness of the science base come from personnel who are knowledgeable about drug development and marketing and are in decision-making roles in companies with real or potential interest in this field. However, these views are taken from a limited sample of such personnel.
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