New episode of the great saga of baclofen, the Afssaps view, on 24 April, new data show clinical benefits in some patients with dependence. A year after a caution against the use out of the marketing authorization, the health authority does so more oppose such a prescription.

The Afssaps recognizes the clinical benefits of baclofen in some patients. Old drug, baclofen (Lioresal and other generic) is a medical specialty prescribed initially in neurology for the treatment of muscle contractures of cerebral origin. For four or five years, it is more and more used in France out of AMM in the management of alcohol.

baclofen authorized

Quarrel about baclofen

In 2008, the publication of the book of the physician Olivier Ameisen “the last drink” (after that of a more confidential in 2004 scientific publication) says the experience of this cardiologist under the influence of alcohol is treated by taking high-dose baclofen, which allowed him to fight against the overwhelming desire drink (or “craving”) alcohol-dependent individuals. Since the “pro-baclos” and the “anti-baclos” continue to quarrel. Lack of interest of a molecule laboratories already génériquée, seeing some addictologues sectarianism with a jaundiced eye possible solution proposed by a cardiologist did not allow the implementation of a study of this molecule on large numbers, have the départager…

In June 2011, the Afssaps goes in the direction of opponents and issued an warning against the use off-AMM of baclofen, regretting the absence of study versus placebo involving enough patients on a long period and soar including possible side effects of this drug at high doses.

In the month of April 2012, the Afssaps authorizes the launch of a controlled clinical trial, patients with high risk alcohol consumption which will be monitored for at least one year.

The Afssaps recognizes the benefits of baclofen in some patients

A recent observational study conducted over one year showed some patients of efficacy (abstinence or reduction of compulsive consumption) including the Afssaps account today. On 24 April, the Afssaps acknowledged “some patients clinical benefits”. Without recommending its use, the Afssaps finds that “treatment with baclofen can be considered on a case by case, prescribed and monitored by practitioners experienced in the management of the dependence” (…) “whether psychiatrists, addictologues, ecologies, or general practitioners, ideally in a multidisciplinary manner”. Therefore prudent prescription authorization pending the implementation of the temporary recommendations of use (RTU) device provided by the law of December 29, 2011.

About possible side effects, the Afssaps there-still seems to have put the water in his wine: “specifically for this use outside the framework of the authorization for placing on the market (AMM), pharmacovigilance data are very limited but do not call into question the continuation of this type of treatment”. The Afssaps judge however that a “better knowledge of the profile of safety of baclofen in this framework is absolutely necessary and justified to maintain a very active monitoring of the Afssaps and health professionals”. She committed to such physicians to include their alcohol-dependent patients in treatment failure in clinical trials.

Beyond the clinical trial authorized by the Afssaps in April 2012, the Agency “encourages the development of other studies that either on the part of teams academic or industry to optimize the use of this molecule”. An application that could find little echo on laboratories, this molecule is fallen in the public domain since long A new update of data inherent in baclofen should be presented within a period of six months.

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New episode of the great saga of baclofen, the Afssaps view, on 24 April, new data show clinical benefits in some patients with dependence. A year after a caution against the use out of the marketing authorization, the health authority does so more oppose such a prescription. The Afssaps recognizes...