FDA Issues Draft Guidance to Help Sponsors Developing Drugs for Alcoholism

The Food and Drug Administration Feb. 11 released a draft guidance to assist sponsors in the development of drugs for treating alcoholism.

A notice announcing the draft guidance was published in the Feb. 12 Federal Register (80 Fed. Reg. 7,8712).

The FDA said there is a need for additional pharmacologic treatments for alcoholism.

The FDA said the draft guidance provides supporting information for endpoints based on patterns of drinking that may be considered appropriate measures of clinical benefit.

Traditionally, alcoholism treatments have been assessed based on the number of patients who refrain from drinking altogether, the agency ...