Updates

Updates

The Food and Drug Administration (FDA) has released new tentative guidelines for assessing the effectiveness of drugs developed for the treatment of alcoholism. Until now, determining whether a medication works has required subjects to remain fully abstinent at the end of a clinical trial. The FDA is proposing changes to the way that clinical benefits of medications for alcoholism are measured, by adding additional outcome measures, such as reduction in drinking to eliminate heavy drinking episodes. Heavy drinking is defined as more than four drinks a day for men and three for women.

These changes, if approved, will open the door for the development of new medications that aim to help people cut back their drinking to levels that are considered low-risk.

“The abstinence-based endpoints have often been considered an unattainable threshold in the clinical trial setting, and may be considered a hindrance to clinical development for drugs to treat alcoholism,” FDA spokesman Eric Pahon told Bloomberg Business. “While total abstinence from alcohol is desirable, reducing heavy drinking to within ‘low-risk’ daily limits presents an alternative goal in drug development so more treatments may be developed.”

Comments and suggestions for the proposed guidelines can be made through April 13, 2015.