Baclofen and alcoholism: a second group of experts gives a favorable opinion … under conditions

Second stage of the process of validation or not of baclofen in the treatment of alcoholism: the Advisory Committee of the French Medicines Agency (ANSM) gave a positive opinion on July 4, 2018, under certain conditions. In particular, the commission asks for a low-dose prescription and only in case of failure of the other strategies, accompanied by a psychological follow-up. In order to make its final decision, the ANSM will have to take into account both this opinion and that of the expert group tasked during the first stage, which rendered an unfavorable opinion.

SUMMARY . Baclofen, prescribed as a muscle relaxant against the contractures of certain neurological diseases, has been authorized since 2014 to treat alcohol dependence, thanks to a temporary recommendation for use (RTU). It is within the framework of this RTU that the maximum dose has been lowered to 80 mg per day following the badysis of the figures of the Health Insurance. According to this study, baclofen in high doses (more than 180 mg daily) more than doubles the risk of death compared to other drugs against alcoholism, and increases the risk of hospitalization by 50%. The decision of the ANSM has been criticized by several specialists, who denounce a lack of consultation, a risk of relapse for alcoholics treated with baclofen and dispute the validity of the study itself. A real headache for the authorities, faced with a risk-benefit ratio still uncertain on the one hand and patients in high demand on the other.

In this context, the application for authorization of placing on the Market (AMM) Baclofen in alcoholism, filed by the Ethypharm laboratory, is subject to a multi-step procedure. The first, an ANSM expert group badysis (CSST) based on existing published data, concluded that the drug was not effective enough.

Positive opinion for baclofen … under conditions

Second stage of the investigation of the MA application for baclofen in the alcolo-dependence: a consultative commission met on July 3 and 4, 2018. The first day was devoted to the hearings of representatives of health professionals and 'Patient badociations' so as to have a global lighting "on the file. The committee then took into account the opinion of the first expert group (CSST), the hearings and the conditions proposed by the Ethypharm laboratory for its MA application.

Result, the commission said to itself " favorable to the use of baclofen in alcoholic patients – dependent ", but not to the conditions proposed by Ethypharm. It considers that baclofen should be prescribed only " after failure of available therapies " at the maximum dose of 80 mg per day. Beyond this dose, the commission recommends a " evaluation and a multidisciplinary care specialized in addictology " systematically because of "increase in the frequency of serious adverse effects ". Finally, any intake of baclofen in alcohol dependence must be " badociated with psychotherapeutic and / or psychocorporeal and / or systematic social care ", according to the commission.

Next step: l ANSM will make its decision on the application for MA of Baclofen, " at the earliest at the start of the academic year (note: in September 2018), on the basis of all these elements ", according to a statement. In the meantime, " the current RTU is maintained "

COMPOSITION OF THE COMMISSION . The advisory committee for baclofen is made up of one-third of each of the three advisory committees charged with providing multidisciplinary insights to ANSM on complex issues (initial evaluation of the benefit / risk ratio, follow-up of this report, and narcotics and psychotropic). Created for a period of 6 years, these 3 commissions are made up of doctors, pharmacists, specialists in the risks and benefits related to health products and users of the health system.