Reason for request

First assessment

  • Key points

Favourable opinion for reimbursement to reduce alcohol consumption, following the failure of other available medicinal treatments, in adult patients with alcohol dependency and high-risk alcohol consumption (> 60 g/day for men and > 40 g/day for women). This opinion is subject to the collection of efficacy and safety data within a maximum period of 3 years with a view to reevaluation.

  • Role in the care pathway?

The management of alcohol dependency is the subject of national recommendations issued by the Société française d’Alcoologie [French Alcohology Society].

In combination with psychosocial follow-up focusing on treatment compliance and the reduction of alcohol consumption, baclofen is a treatment option of last resort to reduce alcohol consumption in adult patients with alcohol dependency and high-risk alcohol consumption (> 60 g/day for men and > 40 g/day for women), not presenting physical symptoms of withdrawal and not requiring immediate abstinence. The potential benefit of the treatment is dictated by the patient’s compliance.

In accordance with the SPC, its use must be accompanied by regular medical follow-up, particularly during the dose titration phase. The maximum daily dosage of baclofen is 80 mg per day. The SPC also specifies that in the absence of any efficacy after 3 months of treatment, the medicinal product should be progressively discontinued and that there are no data from studies beyond 12 months.

  • Special recommendations

The Committee deems that BACLOCUR may be prescribed to alcohol-dependent patients at high risk of failure of other medicinal treatments when it appears to be essential to reduce their alcohol consumption in order to improve their health status or prevent their health from deteriorating.

Detailed information concerning the treatment regimen, its benefits and drawbacks - in particular, adverse effects - should be given to patients before any treatment decision is reached. Their attention should be drawn to the need for regular medical follow-up, especially during the titration phase, in order to determine the optimal dosage (tailored to each patient), i.e., the lowest dose enabling an optimal treatment response and acceptable safety, without exceeding the dose of 80 mg per day.

The Committee will reevaluate the medicinal product within a maximum period of 3 years.

Clinical Benefit


The clinical benefit of BACLOCUR is low in the indication and in strict compliance with the MA dosage (maximum dose of 80 mg per day), pending new data.



Clinical Added Value

no clinical added value


  • demonstration of the superiority of baclofen compared to placebo inadequately established in the MA indication and dosage despite large-scale use of the medicinal product in France, particularly in the context of a temporary recommendation for use (RTU);
  • the effect size of baclofen compared to placebo, which is at best low, observed in a context of discordant, heterogeneous studies with a low level of evidence;
  • the substantial medical need for access to treatments in the management of alcohol dependence, due to the modest efficacy of the treatments available and the lack of any appropriate and reimbursable alternatives in patients in whom these treatments have failed;


the Committee considers that BACLOCUR provides no clinical added value (CAV V) in the current treatment of patients with alcohol dependency.

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