Baclofen, muscle relaxant, allowed under conditions in the treatment of alcoholism

This is the culmination of ten years of hope and controversy: baclofen was allowed Tuesday to treat alcoholism, but at a reduced dose, which
displeased the most ardent supporters of this medicine. Baclofen, a muscle relaxant used by many alcoholics outside its indication of origin, can be marketed in the fight against this addiction, decided the Agency of Medicine (ANSM).

It responded favorably to a request from the Ethypharm laboratory granting it a Marketing Authorization (MA) for the product to be sold under the name Baclocur (10, 20, 40 mg). "It's not a blank check, However, ANSM general director Dominique Martin warned that "this medicine is not insignificant and must be handled with great care ".

Baclofen can be prescribed to alcoholics at a maximum dose of 80 mg / day, after failure of other treatments. This product has been used since the 1970s as a muscle relaxant, but its use has gradually been diverted towards the treatment of alcoholism. This alternative use exploded in 2008 with the publication of Olivier Ameisen's book "Le dernier verre". This cardiologist, who has since died, told in his book how this medicine had suppressed his desire to drink.

Since 2014, baclofen has been licensed for the treatment of alcoholism through a temporary recommendation for use (RTU), now
replaced by the AMM. The decision announced Tuesday comes after a long controversy: the effectiveness of baclofen is deemed unparalleled by its supporters but the ANSM insists on its risks.

The Agency relies on a study conducted with theHealth Insurance. According to her, baclofen in high doses (more than 180 mg per day) more than doubles the risk of death compared to other drugs against alcoholism, and increases the risk of hospitalization by 50%. This is the reason why the ANSM had lowered last year the maximum authorized dose of 300 to 80 mg, to the great fury of some patients, who seized the Council of State in vain.

"Stop or again"

At the origin of these procedures, the badociation Baclohelp challenged Tuesday the threshold of 80 mg / day set in the context of the marketing authorization. "This decision endangers" all patients need to be treated with higher doses, she said in a statement. It announced its intention to attack again this limitation before the Council of State.

Supporters of baclofen rely on several studies, which they say "the efficacy and safety of baclofen up to 300 mg daily "said Baclohelp. The ANSM ensures that the majority of alcoholic patients treated with baclofen take less than 80 mg / day.

"We will exercise an extremely attentive monitoring of this product (that of the Ethypharm laboratory, ed) as soon as it is marketed"insisted Mr. Martin, stating that he could"there are different evolutions".

"If the profit is not the one we expected and if it appears that we must postpone the marketing authorization, we could do it at any time"he warned. "Conversely, if future studies show that in certain situations, it may be useful to exceed 80 mg / day, we are open to changing the AMM" by increasing the maximum allowable dose, he added.

According to his boss, the ANSM took into account a "public health need" to make its decision. "Basically, it was stop or ", he said. Do not grant permission "would not have seemed reasonable to us in view of the needs, the seriousness of the alcoholic disease and the fact that tens of thousands of people are taking this medicine under RTU".

"Finally, baclofen has a marketing authorization: it is cautious with regard to the side effects linked to its use."commented Addictologist Michel Reynaud, Chairman of the Equity Addictions Fund.