In March 2014, the National Agency for the Safety of Medicines and Health Products (ANSM) developed, for a period of 3 years, a Temporary Use Recommendation (RTU) for baclofen in the management of alcohol- dependent.
Pending the results of the CNAMTS-ANSM study on safety, and the final reports of the two clinical studies, Alpadir and Bacloville, the ANSM renews this system for a period of one year. Moreover, following the analysis of tolerance and efficacy data collected since the implementation of the RTU, ANSM has developed a new protocol for treatment and follow-up of patients and has simplified the RTU device, With the objective of securing the use of baclofen in this indication.
In order to regulate the non-marketing use of baclofen (Liorésal 10 mg, scored tablet, Baclofen Zentiva 10 mg, scored tablet) in the treatment of alcohol dependence, on 17 March 2014, the ANSM drew up a Temporary Recommendation d (RTU) for a period of 3 years.
At the same time, two clinical trials, Bacloville and Alpadir , have been conducted in France to assess the efficacy and safety of baclofen.
Pending the results of a CNAMTS-ANSM study on safety and final reports of these two clinical studies, ANSM decided to renew this system for a period of 1 year from 17 March 2017.
Revision of the protocol and simplification of the RTU device
In the past three years, only about 7,000 patients have been registered on the RTU portal.
Given this low rate of adherence by healthcare professionals to the device and the notion of a non-controlled (non-RTU) use of baclofen in alcohol-dependent patients, ANSM has begun a review of The RTU keeping the objective of securing access to baclofen.
The ANSM has set up a Temporary Specialized Scientific Committee (CSST) composed of addictologists, general practitioners and psychiatrists involved in the care of alcohol-dependent patients. This committee was entrusted with the task of reviewing the RTU protocol with the aim of optimizing and improving the adhesion of healthcare professionals to this device for the safety of the patients concerned .
In addition, the pharmacovigilance data for baclofen prescribed in alcohol-dependent patients have been regularly and thoroughly reviewed by the Regional Center for Pharmacovigilance in Amiens and have been discussed in the Pharmacovigilance Technical Committee .
Based on the recommendations of the CSST and the Technical Committee on Pharmacovigilance, a new version of the protocol for baclofen RTU will come into force on 17 March 2017.
In addition, the patient inclusion portal will be removed as this has been found to be too complex by health professionals and has not led to the identification of new pharmacovigilance signals.
As part of the new treatment modalities for this RTU, baclofen can now be prescribed as first-line treatment in the following two situations:
Helps maintain abstinence after weaning;
Reduction in alcohol consumption.
However, caution should be exercised when prescribing baclofen in patients with psychiatric disorders due to the risk of worsening underlying psychiatric illness and / or potential for suicidal risk. Specific modalities for the management of these patients are detailed in the protocol (16/03/2017) application / pdf (532 ko).
For epileptic patients with a history of cometal seizures and for whom a risk of decreasing the seizure threshold is possible because of the prescription of baclofen, this treatment should be introduced very gradually and close monitoring of the patient should be carried out Along with the prescription.
Moreover, it is important to emphasize:
On the one hand, that baclofen therapy should be introduced very gradually and that the dosage should be adjusted according to the tolerance and efficacy observed in the patient;
On the other hand, that the dosage of baclofen should also be decreased very gradually when the treatment is discontinued, taking into account the risk of a baclofen withdrawal syndrome.
Finally, ANSM recalls that any use of baclofen outside the clinical situations covered by the marketing authorization or the RTU creates risks and involves the responsibility of the healthcare professionals.