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Social and Medical Aspects of Drug Abuse pp 157–167Cite as

Naltrexone: Current Clinical Investigations

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Abstract

The National Institute on Drug Abuse (NIDA) has the lead governmental role in developing New Chemical Entities (NCEs) into chemotherapeutic agents for the treatment of drug abuse. The Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) and its sister agency the National Institutes of Health (NIH) jointly share the difficult task of developing agents of little commercial value that are termed orphan drugs. NIDA has identified several substances as being both safe and efficacious in the treatment of opioid abuse. We focus on the process involved in transforming an NCE, EN-1639A (naltrexone), into a chemotherapeutic agent with a New Drug Application (NDA) approved by the Food and Drug Administration (FDA). In addition, specific data that were collected during delays in this process are presented, and the use of this data base to facilitate the NDA process is discussed.

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Authors
  1. Harold M. Ginzburg
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  2. Robert A. Markowitz
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Editor information

Editors and Affiliations

  1. Department of Psychiatry, New York University School of Medicine, New York, New York, USA

    George Serban M.D. (Principal Research Investigator and Clinical Associate Professor) (Principal Research Investigator and Clinical Associate Professor)

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© 1984 Spectrum Publications, Inc.

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Ginzburg, H.M., Markowitz, R.A. (1984). Naltrexone: Current Clinical Investigations. In: Serban, G. (eds) Social and Medical Aspects of Drug Abuse. Springer, Dordrecht. https://doi.org/10.1007/978-94-011-6320-0_15

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  • DOI: https://doi.org/10.1007/978-94-011-6320-0_15

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-011-6322-4

  • Online ISBN: 978-94-011-6320-0

  • eBook Packages: Springer Book Archive

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