France Approves New Drug To Treat Alcoholism
By Maggie Ethridge 11/09/18
Some are concerned about the efficacy of the drug as well as its possible side effects.
French health authorities have approved the use of a muscle relaxant in the treatment of people addicted to alcohol, despite some side effects.
ANSM, the national drug agency, cleared baclofen for alcoholism treatment after a trial period that began in 2014, reported Medical Xpress . Previously, the drug had been used off-label for years in several countries.
Fierce interest in this muscle relaxant as a treatment for alcohol addiction began in 2008 when Olivier Ameisen, a French cardiologist who practiced in the United States, published his book, Le Dernier Verre (“the last drink”).
Ameisen outlines cases of his patients with alcohol use disorder who had failed to remain sober through Alcoholics Anonymous or other common treatments. Using a treatment of high doses of baclofen, Ameisen was able to assist many of his patients in achieving sobriety.
There are concerns about the side effects that come with baclofen. The dosage is limited to 80 milligrams per day, a reduction from the previous 300 milligrams.
Other critics of using baclofen for alcoholism say that its efficacy has not been proven, while others say that treating addiction with another substance is a bad idea.
A French drug oversight agency said last year that baclofen had shown “clinical benefits in some patients,” and despite lack of harder evidence, the country appears more concerned about providing options for those addicted than ensuring solid evidence before opening access for treatment.
The trial included 132 heavy drinkers. After being treated with baclofen, 80% either became abstinent or drank moderately. Two other drugs commonly used to treat alcoholics, naltrexone and acamprosate, have a success rate of 20 to 25%.
Medical Xpress reported that ANSM director Dominique Martin said that the authorization of baclofen (sold under brand names including Kemstro, Lioresal and Gablofen) was important to meet “a public health need.”
Martin went on to say that holding back approval of the drug “did not seem reasonable to us given the needs and the seriousness of alcoholism, and the fact that tens of thousands of people are taking the medicine for this treatment,” he said.