FDA Proposal – Alcoholism Drugs and Sobriety

OLYMPUS DIGITAL CAMERAOver the years there have been a number of drugs developed for the treatment of substance use disorders, such as Vivitrol (naltrexone) and Acamprosate (Campral). Why these drugs have proven effective in mitigating cravings and pleasure received from drinking alcohol, they do not guarantee that patients will stay abstinent from alcohol. Researchers have long been seeking to develop drugs that would lead to total abstinence, with varying levels of success.

While the end goal should be and will continue to be long term sobriety, the Food and Drug Administration (FDA) recently proposed that drugs to treat alcoholism would not have to lead to sobriety in order to gain approval from the agency, Bloomberg Business reports. The FDA would give drug companies approval for alcohol treatments drugs as long as it can be proved that patients using them no longer drink heavily.

This week, the FDA released new draft guidelines for drug companies who would like to develop alcoholism treatments, according to the article.

“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,” said Eric Pahon, an FDA spokesman. “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.”

The dream of one day formulating drugs that would cure different forms of addiction may be possible. For now, the drugs currently available have proven to be effective in a number of cases, especially when used in conjunction with a program of recovery. Addiction is a complex disease that has proven difficult to understand, mandating that drugs lead to sobriety could prove harmful to future research

The FDA proposal is open for comment by industry, researchers and addiction and recovery groups for 60 days, the article notes.