Approval of New Drugs, Medical Devices/Technology

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Appendix E: Selection Criteria And Discussion

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Appendix E: Selection Criteria And Discussion Guide For Interviews With Private Firms

Interviews With Private Firms

Appendix C: Need For Substance Abuse Treatment

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Appendix C: Need For Substance Abuse Treatment

Table: Need for Cocaine Treatment

Appendix D: Literature Search Strategies For Case

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Appendix D: Literature Search Strategies For Case Study Reports Of LAAM, Naltrexone, Clozapine, And Nicorette

Literature Search Methods for LAAM Case Study

Appendix B: Summaries of Primary Studies on Need

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Appendix B: Summaries of Primary Studies on Need for Cocaine Treatment

ABT ASSOCIATES (Rhodes et al. 1993, 1995) Rhodes, W. (1993). Synthetic Estimation Applied to the Prevalence of Drug Use. The Journal of Drug Issues 23(2), 297-321. ESTIMATES ABT ASSOCIATES (Rhodes et al., 1993) Estimate (in thousands) Cocaine Total(1990) 2,036

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Appendix A: Market Analysis Model

Drug development decisions on the part of pharmaceutical companies are based largely on determinations of risk-reward tradeoffs inherent in scientific and market factors. As described in this report, companies often have summary financial targets or hurdles that drive investment decisions. Two indicators of projected or actual financial performanc

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. References

21 CFR 291 Drugs Used for Treatment of Narcotic Addicts. Abt Associates. Rhodes W, Scheiman P, Pittayathikhum T, Collins L, and Tsarfaty V. Synthetic estimation applied to the prevalence of drug use. The Journal of Drug Issues . 1993;23(2): 297 - 321. Agency for Health Care Policy and Research. Smoking cessation guideline technical report, nu

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Interviews with Private Firms

We interviewed five private firms, one at a time, to explore and characterize their views on market barriers to the development of cocaine abuse pharmacotherapies and on the readiness of the science base in developing such medications. One of the companies was a large pharmaceutical company; one was a large pharmaceutical company with a strong CNS

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Case Studies

For each of the case studies, we used several different kinds of sources to collect information on the market barriers to the development of each drug. For each case study, we conducted a thorough literature search, including peer-reviewed sources, and the gray literature. The information gathered from print materials was supplemented with intervi

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Scenarios of Company Decision Making

The Lewin Group adapted the quantitative model to test hypothetical scenarios of company decision making. Modeling of the scenarios made it possible to examine whether a particular product development opportunity might appear more or less attractive to pharmaceutical companies and their investors. The scenarios help to illustrate some of the key b

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Market Analysis Model

Drug development decisions of pharmaceutical companies are primarily based on business and economic factors--essentially whether a particular potential medication might be sufficiently profitable if it is successfully developed. Expected profitability of a particular product is determined by a combination of such factors as:

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Market Analysis for a Prospective Cocaine Medication

We performed a market analysis for a prospective cocaine medication from a pharmaceutical company's perspective. The purpose of this market analysis was to estimate how costs and revenues would be accrued over time in the development and commercialization of a prospective cocaine medication. We first focused on estimating the market size for sub

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Study Methods

We used several sources to collect information about substance abuse pharmacotherapies (e.g., cocaine) and the market barriers to the development of such drugs. We completed a market analysis for cocaine pharmacotherapy; several hypothetical scenarios of pharmaceutical decisionmaking; four case studies of selected pharmacotherapies; and detailed i

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Introduction

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 medicat

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Extended Market Exclusivity

The prospect of splitting a small market with competitors may render a project financially infeasible. Provisions for market exclusivity via the existing Orphan Drug Act and the 1984 Drug Price and Competition and Patent Term Restoration Act, and/or similar means are necessary but not sufficient for lowering the barrier of a small and uncertain ma

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Guaranteed Market

Through purchase orders or other means, government and/or other major payers could guarantee a substantial minimum market for a cocaine addiction pharmacotherapy. Guaranteeing a market in terms of number of patients and/or a number of drug units, a given price, and a specified period of time, would address directly the barrier of limited and uncer

Expansion and Enhancement of Substance Abuse

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Expansion and Enhancement of Substance Abuse Treatment System

Improving the substance abuse treatment system can address a critical barrier to market access. Greater funding of treatment centers could increase the number of patients treated. It could also increase available spending per patient, enabling greater market penetration and more substantial prices for effective drugs. Requiring all substance abuse

Government Funding of New Drug Development

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Government Funding of New Drug Development

In general, the investment to produce a new drug for a small market is no different than producing a new drug for a large market, but a company is less likely to recoup its investment in a small market. Government funding of new drug development can raise the science base and move any promising drug closer to launch. Improving the science base can

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Overcoming Critical Market Barriers

Any public policies intended to improve opportunities for developing pharmacotherapies for cocaine addiction must address the three critical barriers described here. It is not within the scope of this study to identify or analyze specific public policies to promote development or marketing of pharmacotherapies for substance abuse.

Industry Perception of Science Base Readiness

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Industry Perception of Science Base Readiness

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

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