/Baclofen: an expert report concludes with a “negative” risk-benefit ratio
Baclofen: An Expert Report Concludes With A “negative” Risk Benefit Ratio

Baclofen: an expert report concludes with a “negative” risk-benefit ratio

In view of the elements provided by the manufacturer of baclofen to the health authorities, its effectiveness in treating alcoholism is “clinically insufficient” according to a committee of independent experts, who also judge the benefit/risk ratio “negative”.

Baclofen: an expert report concludes with a risk-benefit ratio

“The efficacy of baclofen in reducing alcohol consumption in adult patients with alcohol dependence and high-risk alcohol consumption, as presented in the marketing authorization application dossier the market (MA), [est jugé] clinically insufficient”, concludes a committee of independent European experts, in an opinion submitted on April 24 to the ANSM, which had commissioned this expertise.

“This, together with a potentially increased risk of developing serious adverse events (including fatalities) particularly at high doses, leads to the consideration that the benefit/risk ratio [du baclofène] is negative”, complete the authors.

The ANSM specifies that before any decision is taken on the file, this expert analysis must be supplemented by the hearing of the practitioners as well as the patients using this drug. On July 3 and 4, the agency will convene a temporary commission, notably made up of doctors and pharmacists, to hear the learned societies and patient associations concerned. These hearings will be broadcast live on the Internet.

Baclofen has been prescribed since the 1970s as a muscle relaxant. In France, it has been authorized since 2014 to treat alcohol dependence, thanks to a temporary recommendation for use (RTU) and was the subject of a marketing authorization application in April 2017 ( AMM) from the Ethypharm laboratory for the treatment of alcohol dependence.

with AFP