Baclofen: the French Medicines Agency makes an unfavorable opinion on its commercialization

The National Agency for the Safety of Medicines (ANSM) gave this Thursday an unfavorable opinion for the marketing of Baclofen as a treatment for alcoholism. The drug may, however, still be prescribed, under certain conditions.

Faced with the controversy surrounding the marketing of Baclofen, the National Agency for Drug Safety (ANSM) has decided. This Thursday, July 5, a commission of experts gave an unfavorable opinion for the marketing of the drug of the laboratory Ethypharm in the treatment of alcoholism. However, it may continue to be used by alcohol dependents, under certain conditions.

The final decision whether or not to grant marketing authorization (MA) for Baclofen comes back to the ANSM, who said it will be known "at the earliest as of September".

300 to 80 mg daily

Initially prescribed as a muscle relaxant in the treatment of 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 could 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 particularly in July 2017, when the ANSM published a study co-published by the National Health Insurance Fund (CNAM) and Inserm, concluding that the safety level of the drug is "of concern" when used at high doses in alcoholics. In the wake, the ANSM has reduced the prescription dose to 80 mg per day, against 300 mg previously "given the increased risk of hospitalization and death".

It is also in the context of reduced doses that the Agence du médicament proposes to maintain its authorization to use Baclofen. It considers it "after failure of available therapies with the objective of reducing alcohol consumption to a level of low risk consumption (less than or equal to 40 g / d for men and less than or equal to at 20g / day for women) The drug can be prescribed by any doctor up to the dosage of 80 mg / day.

Beyond this dose, "the prescriber must systematically offer the patient a multidisciplinary assessment and management specializing in addiction, especially given an increase in the frequency of serious adverse effects with the increase in doses", specify the experts.

Essential psychotherapeutic follow-up

The Committee of Experts is also responsible for recommending to any patient taking Baclofen to turn to "psychotherapeutic and / or psychocorporeal and / or social, systematic". It is also necessary to refer patients for advice or follow-up to a psychiatrist if they have psychiatric disorders, regardless of the dose of medication prescribed.

Finally, it considers that the dose of Baclofen prescribed must be "re-evaluated regularly" and that its prescription "must be accompanied by a booklet for monitoring and promoting the proper use of Baclofen".

A placebo?

Thus framed, the marketing of Baclofen as a treatment for alcoholism can it really cure alcohol-dependent people? While the Committee of Experts emphasizes the importance of reducing doses and accompanying the prescription of a psychotherapeutic follow-up, other experts insist on the relative effectiveness of this drug.

In May 2017, the ALPADIR study published in Alcohol and Alcoholism demonstrated that Baclofen does not cause a major difference compared to placebo. 320 alcoholic adults were recruited in the French addiction services. Baclofen was prescribed half of them, while the other volunteers received a placebo. It was observed after six months of treatment that the molecule had a low efficacy: 12% of patients on drug did not consume alcohol for 20 consecutive weeks, against 10.5% in the placebo group.

Video: Baclofen: What You Need To Know (November 2019).