Naltrexone in addicted business executives and physicians.

Area of Science:

• Pharmacology
• Drug Safety and Efficacy
• Addiction Medicine

Background:

• Naltrexone is a synthetic, long-acting narcotic antagonist.
• Decades of research by the National Institute on Drug Abuse (NIDA) have focused on narcotic antagonists.
• The Food and Drug Administration (FDA) is currently reviewing naltrexone.

Purpose of the Study:

• To evaluate the safety and efficacy of naltrexone.
• To determine naltrexone's suitability for marketing as a prescription medication.
• To support the maintenance of an opioid dependence-free state in former narcotic abusers.

Main Methods:

• Review of preclinical data, including toxicology, reproduction, teratology, and carcinogenicity studies.
• Review of clinical trial data from Phase I, Phase II, and Phase III studies.
• Assessment of naltrexone as an orally administered medication.

Main Results:

• The FDA is conducting a comprehensive review of naltrexone's preclinical and clinical data.
• The data aims to establish the drug's safety and effectiveness profile.
• Naltrexone is being considered for approval as an adjunct therapy.

Conclusions:

• FDA approval of naltrexone would signify a major advancement in addiction treatment.
• Naltrexone is intended for use as an unscheduled prescription medication.
• Successful review will allow naltrexone to be available for former narcotic abusers.