February 26, 2015 Leave a comment
This February, the FDA suggested new guidelines for drug makers interested in developing treatments for alcoholism. In a groundbreaking departure from conventional thinking, the guidelines would give drug companies the green light to develop treatments that help patients stay within “low-risk” daily alcohol limits.
Presently, the goal of pharmaceutical treatments for alcoholism is total abstinence from drinking alcohol.
In a February 11 bloomberg.com post, FDA spokesman Eric Pahon explained that abstinence-based endpoints are often unattainable in a clinical trial, which can hinder the development of drugs to treat alcoholism. “Reducing heavy drinking to within ‘low-risk’ daily limits presents an alternative goal in drug development so more treatments may be developed,” Pahon said.
John Larson, M.D., Corporate Medical Director of Gateway Alcohol and Drug Treatment Centers, agrees. “While complete avoidance of alcohol is necessary for some to achieve meaningful recovery, there are others whose lives could greatly benefit from treatment that successfully reduces the amount and frequency of alcohol use without requiring total abstinence. These new FDA guidelines could aid in the discovery of whole new categories of medications that could do just that,” said Dr. Larson.
The Need for New Medications
There are currently three categories of drugs sold to treat alcoholism. In addition to having limitations, these medications are only effective for some.
Despite this, no new medications have been introduced into the alcohol treatment market in nearly ten years. Reaching the high bar of total sobriety in a clinical trial consistently proves elusive.
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) acknowledges more medications are needed to serve the broader population. Dr. Raye Litten, associate director of the agency’s Division of Treatment and Recovery Research, believes more treatments will enable more patients to find one that works for them.
The FDA proposal identifies alcoholism as continued drinking despite physical and psychosocial consequences. The agency said an alcoholism drug should ultimately improve those consequences, which can be done via total sobriety or a reduction in alcohol use.
Michael Darcy, Gateway’s CEO & President, backs this thinking. He said, “It seems the substance abuse disorder field is the only profession that claims a 100% rate of no relapses as the criteria for success. I hope this (new) notion will lead to a more realistic view of success.”
To learn more about treatment options for alcohol abuse issues, or our free, confidential consultation, call Gateway Alcohol & Drug Treatment Centers today at 877-505-HOPE (4673).