Content by Keyword: Drugs, Medical Devices, and Pharmacy Services

There are multiple, interrelated aspects of the current substance abuse treatment system that limit the market prospects for any new pharmacotherapy for cocaine addiction. These limitations are apparent in the case studies, were raised by company executives interviewed for this study, and are corroborated by modeling of certain scenarios. Sales of

The small size and uncertainty of the market for cocaine pharmacotherapies constitutes a critical barrier to development of a cocaine abuse pharmacotherapy. Although all of the company executives interviewed for this study agreed that the total number of cocaine users is appreciable, they recognized that the feasible market for a cocaine abuse tre

Many of the market barriers identified in the 1995 IOM report were confirmed through the sources used for this study. Although no new general types of new market barriers were identified in this study, certain ones were elaborated or described in a more contemporary context.

Under current conditions, pursuing development of a new cocaine pharmacotherapy via a typical full product development cycle is not economically viable from the standpoint of industry. Although a variety of hurdles or procedural impediments may affect prospects for new pharmacotherapy development in this area, most of these are regarded as surmoun

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 b

Social stigma of drug abusers was cited as a market barrier by representatives of two of the pharmaceutical companies, though it is regarded as surmountable if the commercial and scientific viability of the product is favorable. The pharmaceutical companies that identified social stigma as a barrier were familiar and sympathetic to the case experi

Two market barriers related to drug marketing were identified. As previously described, the possibility of the pharmacotherapy being distributed through publicly-funded treatment centers rather than through physician offices was a concern of the pharmaceutical companies because of the companies' limited access to patients.

The clozapine case study demonstrates that special requirements for approved use and other atypical restrictions can pose significant market barriers. Clozapine has a potentially fatal side-effect, agranulocytosis, that warrants strict patient monitoring. This contributed to clozapine's being approved as a second- or third-line therapy, i.e., for

DEA regulation was not generally cited by pharmaceutical company representatives as a market barrier. One interviewee mentioned the potential risk of exposing an existing successful product used for other indications to cocaine treatment. The company indicated that the increase in development costs of the drug and the potential for rescheduling of

The uncertainty associated with designation of required clinical endpoints to be used in clinical trials of medications for cocaine addiction was cited as a market barrier, though not a major one. Two pharmaceutical company interviewees identified this ambiguity as a potential barrier, and one company representative expressed some concern that "ch

Three of the four case study drugs were for patient populations perceived to be difficult to study for a variety of reasons (e.g., patient recruitment, compliance, and co-morbidities). For example, patient compliance has been seen as a barrier to the success of naltrexone in both the heroin addiction and alcoholism markets, because the drug is not

Several points within the drug approval process were seen by industry as potential market barriers to product development in this field. However, as a group, none were viewed as major barriers that could not be surmounted, especially if the market barriers cited as critical ones above were lowered or eliminated.

Another critical market barrier is the uncertainty surrounding the reimbursement of cocaine abuse and addiction treatment. The pharmaceutical company respondents, as well as one from a VC firm, voiced their concern over the heavy reliance of the substance abuse market on federal and state government reimbursement. The perception among the drug com

There was consensus among the pharmaceutical company representatives that the current substance abuse treatment system constitutes a great market barrier that severely limits opportunities for market penetration.

The small size and uncertainty of the market for cocaine pharmacotherapies constitutes a critical barrier to development of a cocaine abuse pharmacotherapy. Although all of our interviewees agreed that the total number of cocaine users is large, they recognized that the market for a cocaine abuse treatment is likely to be much smaller than the abs

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 limi

Venture capital firms (VCs) reported market potential (e.g., projected revenues) and probability of financial success as the main factors guiding investment decisions on new products. VC interviewees suggested that the evaluation of pharmacotherapies is no different from that of any other product or business plan. These companies are most interest

As discussed above, a pharmaceutical company's decision to develop and market a drug is predicated on a number of factors related to the probability of economic success of a given product. Each of the several companies that were interviewed for this study indicated that the evaluation of a candidate drug project hinged on an overall assessment of