FDA Alcoholism Developing Drugs for Treatment

标准简介

标准截图

标准文档说明

标准部分原文

Draft — Not for Implementation 1 Alcoholism: Developing Drugs for Treatment 1 2 Guidance for Industry 3 4 5 6 7 This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current 8 thinking on this topic. It does not create or confer any rights for or on any person and does not operate to 9 bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of 10 the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA 11 staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call 12 the appropriate number listed on the title page of this guidance. 13 14 15 16 17 I. INTRODUCTION 18 19 The purpose of this guidance is to assist sponsors in the clinical development of drugs for the 2

20 treatment of alcoholism. There are many different terms, definitions, and diagnostic criteria that 21 have been used to describe this condition. However, in this guidance, we use the term 22 alcoholism to describe patients with alcohol use problems that would make them candidates for 3

23 treatment with medication. As the World Health Organization (WHO) notes, alcoholism is a 24 “term of long-standing use” and is “generally taken to refer to chronic continual drinking or 25 periodic consumption of alcohol which is characterized by impaired control over drinking, 26 frequent episodes of intoxication, and preoccupation with alcohol and the use of alcohol despite 27 adverse consequences.” Further discussion of terminology can be found in Appendix 1. 28 29 We are issuing this guidance to better communicate our current thinking on the appropriate 30 endpoints for clinical trials of drugs to treat alcoholism, and to apprise sponsors of possible 31 alternatives to abstinence-based endpoints, which have often been considered an unattainable 32 threshold in the clinical trial setting, and which may be considered a hindrance to clinical 33 development for drugs to treat alcoholism. This guidance provides supporting information for 34 the endpoints as appropriate measures of clinical benefit. This draft guidance is intended to 35 serve as a focus for continued discussions among the Division of Anesthesia, Analgesia, and 1

This guidance has been prepared by the Division of Anesthesia, Analgesia, and Addiction Products in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. 2

For the purposes of this guidance, all references to drugs include both human drugs and therapeutic biological products unless otherwise specified. 3

http://www.who.int/substance_abuse/terminology/who_lexicon/en/ (accessed 2/1/14) 1

网盘链接

百度网盘：https://pan.baidu.com/s/1jQo0PgOVCJ_PEbsgcPyofg
提取码：fj6j