'Anti-alcoholism' drug cleared for use in France

French health authorities have approved the use of a drug, originally designed to treat nervous spasms, for the treatment of alcoholism on a "case by case" basis.

AFSSAPS, the regulator that authorises drugs, said that while the Baclofen had not been definitively shown to be efficient in the treatment of alcoholism, it had shown "clinical benefits in some patients".

It recommended in a statement that Baclofen -- the lab name for a medication branded as Kemstro, Lioresal and Gablofen -- should be considered on a "case by case" basis.

The history of the drug goes back 50 years. It was originally designed for epilepsy before becoming licensed to treat spasticity, but researchers are now interested in using it to ease alcoholic craving.

Interest was sparked in 2008 by a book, "Le Dernier Verre" (The Last Drink), by cardiologist Olivier Ameisen, who self-treated his alcoholism with high doses of Baclofen.

The AFSSAPS statement came after French doctors said last month that the drug had cleared an important early test. The trial entailed enrolling 132 who were given Baclofen at high doses over a year.

Eighty percent either became abstinent or turned into . By comparison, two drugs that are commonly used to treat alcoholics, naltrexon and , yield a success rate of 20-25 percent.

Side effects included fatigue, drowsiness, insomnia, dizziness and digestive troubles.

Lead researcher Philippe Jaury of the University of Paris-Descartes said the outcome opened the door to one-year clinical trials, expected to start in May, in which 320 alcoholics would be divided into two groups.

One batch will receive Baclofen, progressively building in dosage until the craving symptoms subside, while the others will receive an inactive look-a-like pill, or placebo.

France's health system is paying 750,000 euros ($469,000) of the 1.2-million-euro ($1.45-million) cost of the trial, and an unidentified donor is paying the rest, Jaury told AFP.

The pre-trial study was published in a specialist journal, and Alcoholism.

add to favorites email to friend print save as pdf

Related Stories

'Anti-alcoholism' drug clears key test hurdle

Mar 20, 2012

A drug designed to treat nervous spasms has cleared an important early test in a project to see whether it can also cure alcoholism, French doctors said on Tuesday.

Acamprosate prevents relapse to drinking in alcoholism

Sep 08, 2010

Acamprosate reduces the number of patients being treated for alcoholism who return to drinking, according to a new Cochrane Systematic Review. The drug showed moderate benefits in trials when used in addition to non-drug treatm ...

New drug may reduce seizures in epilepsy

Apr 13, 2011

A new drug called perampanel appears to significantly reduce seizures in people with hard-to-control epilepsy, according to results of the first clinical trial to test the higher 12 mg dose of the drug. The late-breaking ...

New leads on the causes of alcoholism

Apr 04, 2011

In order to develop new medications for alcoholism, researchers need to understand how alcohol acts on the brain's reward system. A previously unknown mechanism has been shown to block the rewarding effects of alcohol on ...

Recommended for you

FDA OKs Cubist antibiotic for serious infections

Dec 20, 2014

The Food and Drug Administration has approved a new medicine to fight complex infections in the abdomen and urinary tract, the fourth antibiotic the agency has approved since May.

Xtoro approved for swimmer's ear

Dec 18, 2014

(HealthDay)—Xtoro (finafloxacin otic suspension) eardrops have been approved by the U.S. Food and Drug Administration to treat swimmer's ear, clinically known as acute otitis externa.

Drug interaction identified for ondansetron, tramadol

Dec 18, 2014

(HealthDay)—In the early postoperative period, ondansetron is associated with increased requirements for tramadol consumption, according to a review and meta-analysis published online Dec. 10 in Anaesthesia.

New system targets germs in donated blood plasma

Dec 17, 2014

(HealthDay)—A new system designed to eliminate germs in donated blood plasma and reduce the risk of transmitting a plasma-borne infection has been approved by the U.S. Food and Drug Administration.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.