The controversy around baclofen continues: an expert committee commissioned by the French Medicines Agency has deemed the efficacy of baclofen “clinically insufficient” in the treatment of alcoholism, while a marketing application has been submitted. filed.
On April 24, un expert committee appointed by the French Medicines Agency judged the efficacy of the drug to be “clinically insufficient” in the treatment of alcohol dependence. LThe committee further considers that this muscle relaxant presents “a potentially increased risk of developing serious adverse events (including death, editor’s note), particularly at high doses “ and that this may lead “to consider that the benefit-risk ratio is negative”.
Soon a temporary committee bringing together experts and associations
Prescribed for this purpose since 2014 as part of a temporary recommendation for use (RTU), the National Medicines Safety Agency (ANSM) published a study co-carried out by the National Health Insurance Fund (CNAM) and Inserm, concluding that the level of safety of the drug was “worrying” when it is used in high doses in alcoholics. In the process, the ANSM reduced the prescription dose to 80 mg per day, against 300 mg previously “given the increased risk of hospitalization and death”.
Experts in alcohol addiction fear that this new dosage will not be enough. “The decrease in doses can only be done gradually,” explains the generalist branch of the Addiction Federation. in a press release. A certain number of general practitioners will continue to prescribe sufficient doses of baclofen, excluding RTUs and marketing authorizations.
But a year ago, the Ethypharm laboratory applied for a marketing authorization (MA) in order to market baclofen in the treatment of alcoholism officially and definitively. The study of the expert committee commissioned by the Medicines Agency was the first step in the process. The next one will be a temporary committee bringing together experts and patient associations on July 3 and 4. The ANSM will rule “at the latest at the start of the school year” in September on this issue, indicated its director general, Dominique Martin, but it “waits to have all the opinions – learned societies, patient associations and experts in the field of commission – before deciding and taking its MA decision “.
How does baclofen work?
As we explained to you in 2013, baclofen acts in the brain at the level of the reward system. During a pleasant experience, this neural network releases large amounts of dopamine, which makes you want to repeat the experience regularly. All addictive drugs artificially increase the amount of dopamine in the reward circuit. The drugs used against addictions therefore attempt to reduce the release of dopamine by acting on the various receptors which ensure communication between neurons.
Unfortunately, baclofen does not always work, without us fully understanding why and especially for whom. It seems that the best results are obtained in patients suffering from very strong compulsive cravings, which addictologists call “craving”. They also observe that the higher the patient’s alcohol consumption before treatment, the greater the dose of baclofen required.
“Of course there are side effects at first”
A patient seized the Council of State on January 24 to demand the right to prescribe baclofen in high doses to alcoholics. “There is a real emergency: 40,000 people are in immediate danger relapse into their alcohol addiction, “said her husband Thomas Maës-Martin, founder of the collective Baclohelp Quoted by West France. Two appeals were filed: one for annulment to challenge the ban and the other to request its urgent suspension.
“Of course there are side effects at first mainly psychiatric, concedes Thomas Maës-Martin, reason for which this drug must be given by competent doctors. But it passes after three months and baclofen can get people 30 years old from alcoholism in a few months. ”But is Baclofen really effective in weaning people addicted to alcohol?
Drug or placebo?
The ALPADIR study published in Alcohol and Alcoholism in May 2017, demonstrated that baclofen does not cause a major difference compared to a placebo. 320 adult alcoholics were recruited from French addiction services. Half of them were prescribed Baclofen, while the other volunteers were given a placebo. It was observed after six months of treatment that the molecule had a low efficacy: 12% of patients on medication did not consume alcohol for 20 consecutive weeks, against 10.5% in the placebo group.
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