neuro equipoise
07-31-2004, 08:00 AM
Excerpt:
"Campral Found Safe and Effective in Trials
The U.S. Food and Drug Administration has approved the drug acamprosate
for treating alcohol dependent individuals seeking to continue to remain
alcohol-free after they have stopped drinking.
Acamprosate, marketed under the brand name Campral, has been used for
years in Europe for treating alcoholics. Campral is the first new drug
approved for alcohol abuse in a decade.
In approving acamprosate, the FDA said Campral may not be effective in
patients who are actively drinking at the start of treatment, or in
patients who abuse other substances in addition to alcohol.
According to the press release issued by the FDA in connection with the
approval:
"While its mechanism of action is not fully understood, Campral is
thought to act on the brain pathways related to alcohol abuse. Campral
was demonstrated to be safe and effective by multiple placebo-controlled
clinical studies involving alcohol-dependent patients who had already
been withdrawn from alcohol, (i.e., detoxified).
Maintaining Alcohol Abstinence
"Campral proved superior to placebo in maintaining abstinence (keeping
patients off alcohol consumption), as indicated by a greater percentage
of acamprosate-treated subjects being assessed as continuously abstinent
throughout treatment.
Campral is not addicting and was generally well-tolerated in clinical
trials. The most common adverse events reported for patients taking
Campral included headache, diarrhea, flatulence, and nausea.
"Treatment with Campral should be part of a comprehensive management
program that includes psychosocial support. Campral is manufactureed by
Lipha Pharmaceuticals, Inc. in Lyon, France."
http://alcoholism.about.com/od/meds/a/blfda040720.htm
"Campral Found Safe and Effective in Trials
The U.S. Food and Drug Administration has approved the drug acamprosate
for treating alcohol dependent individuals seeking to continue to remain
alcohol-free after they have stopped drinking.
Acamprosate, marketed under the brand name Campral, has been used for
years in Europe for treating alcoholics. Campral is the first new drug
approved for alcohol abuse in a decade.
In approving acamprosate, the FDA said Campral may not be effective in
patients who are actively drinking at the start of treatment, or in
patients who abuse other substances in addition to alcohol.
According to the press release issued by the FDA in connection with the
approval:
"While its mechanism of action is not fully understood, Campral is
thought to act on the brain pathways related to alcohol abuse. Campral
was demonstrated to be safe and effective by multiple placebo-controlled
clinical studies involving alcohol-dependent patients who had already
been withdrawn from alcohol, (i.e., detoxified).
Maintaining Alcohol Abstinence
"Campral proved superior to placebo in maintaining abstinence (keeping
patients off alcohol consumption), as indicated by a greater percentage
of acamprosate-treated subjects being assessed as continuously abstinent
throughout treatment.
Campral is not addicting and was generally well-tolerated in clinical
trials. The most common adverse events reported for patients taking
Campral included headache, diarrhea, flatulence, and nausea.
"Treatment with Campral should be part of a comprehensive management
program that includes psychosocial support. Campral is manufactureed by
Lipha Pharmaceuticals, Inc. in Lyon, France."
http://alcoholism.about.com/od/meds/a/blfda040720.htm