The National Medicines Safety Agency (ANSM) on Thursday issued an unfavorable opinion for the marketing of Baclofen as a treatment for alcoholism. However, the drug may still be prescribed, under certain conditions.
Faced with the controversy surrounding the marketing of Baclofen, the National Medicines Safety Agency (ANSM) has ruled. This Thursday, July 5, a committee of experts issued an unfavorable opinion for the marketing of the drug from the laboratory Ethypharm in the treatment of alcoholism. However, it may continue to be used by alcohol addicts, under certain conditions.
The final decision to grant or not the marketing authorization (MA) of Baclofen, however, rests with the ANSM, which has indicated that it will be known “at the earliest in the beginning of the school year”.
300 to 80 mg per day
Originally prescribed as a muscle relaxant as part of a treatment for multiple sclerosis, Baclofen has gradually been used to treat alcoholism. In 2014, the ANSM even issued a temporary recommendation for use (RTU) so that Baclofen can continue to be prescribed to alcohol-dependent people. This authorization remains valid until March 2019.
The controversy surrounding the use of Baclofen as a treatment for alcoholism began in particular in July 2017, when the ANSM published a study co-conducted by the National Health Insurance Fund (CNAM) and Inserm, concluding that the safety level of the drug is “worrying” when used in high doses in people with alcoholism. 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”.
It is moreover in the context of reduced doses that the Medicines Agency proposes to maintain its authorization for the use of Baclofen. She considers it “after failure of available therapies with the objective of reducing alcohol consumption to a low-risk level of consumption (less than or equal to 40 g / d for men and less than or equal to at 20g / d for women). The drug can be prescribed by any doctor up to a dosage of 80 mg / day “.
Beyond this dose, “the prescriber must systematically offer the patient an evaluation and multidisciplinary management specializing in addictology, particularly in view of an increase in the frequency of serious adverse effects with increasing doses”, specify the experts.
An essential psychotherapeutic follow-up
The committee of experts is also responsible for recommending to any patient taking Baclofen to turn to “systematic psychotherapeutic and / or psycho-corporal and / or social care”. It is also necessary to refer the patient for advice or follow-up to a psychiatric doctor if he presents with psychiatric disorders, regardless of the dose of medication prescribed.
Finally, it considers that the dose of Baclofen prescribed must be “reassessed regularly” and that its prescription “must be accompanied by a booklet for monitoring and promoting the proper use of Baclofen”.
A placebo?
Thus framed, can the marketing of Baclofen as a treatment for alcoholism really treat alcohol-dependent people? If the committee of experts insists on the importance of reducing the doses and accompanying the prescription of psychotherapeutic monitoring, other experts insist on the relative effectiveness of this drug.
In May 2017, the ALPADIR study published in Alcohol and Alcoholism has shown 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.
.