BACLOFENE ZENTIVA (baclofene)

 Key points

Favourable opinion for reimbursement to reduce alcohol consumption, following the failure of other available medicinal treatments, in adult patients with alcohol dependence and high-risk alcohol consumption (> 60 g/day for men and > 40 g/day for women).

The Committee makes maintenance of this opinion conditional on the reevaluation of BACLOFEN ZENTIVA (baclofen), within a maximum period of 3 years, based on the collection of efficacy and safety data for baclofen, firstly, and, secondly, on data concerning its conditions of use in its indication (see “Committee’s recommendations” section).

Role in the care pathway?

The management of alcohol dependence 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 dependence 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 BACLOFEN ZENTIVA (baclofen) 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, at the same time as the proprietary medicinal product BACLOCUR (baclofen).