What will become of the baclofen ? Four months after having obtained the renewal of its recommendation temporary use (RTU) granted in march 2014, the benefit-risk of this molecule for the reduction of alcohol consumption in the most dependent people, or even bring them on the path of abstinence, is called into question. A study carried out by the Cnam and the Inserm published at the beginning of the month of July has been alerted on the risk of hospitalization and even death due to a use of the molecule at very high dose. According to the two organizations, the risk is moderately increased with an outlet between 75 and 180 mg per day, and are highly beyond Following this publication, the national security Agency of the drug (MSNA) has taken strong measures, Tuesday, July 25. She may not use baclofen at a high dose in the context of the temporary recommendation of use, and set a maximum threshold of 80 mg/day (compared to 300 mg previously), requiring a gradual lowering of the dosage for patients beyond this threshold.
The defenders of the baclofen shriveled
The defenders of the baclofen have responded without delay. A dozen doctors/professors of psychiatry and addiction, had sent a tribune to the press, denouncing the decision as “a source of a loss of opportunity for many patients”. And they add: “clinical experience and scientific data show, however, that the baclofen is active at doses averaging around 150 to 180 mg.”
“We went from everything to nothing,” said Bernard Granger, one of the signatories, interviewed by The Tribune. “The vast majority of patients that we, as specialists and academics in the field, process, need more than 80 mg. Lower their treatment puts them at risk of relapse.”
Effects already mixed, even at high dose
The decision of the MAN putting on the harness a molecule that, according to clinical studies, works well at very high dose, but not for all patients. In detail, the results of study Bacloville conducted by the APHP and published by the end of 2016, shows a abstinence or reduction of consumption to a “medically correct” in 56.8% of patients treated with large daily doses of baclofen (160 mg, on average), compared to 36.5% for the placebo. The study Alpadir, conducted by the French laboratory Ethypharm with a dosage of 180 mg/day did not show significant effects on abstinence compared to placebo (11.9% versus 10.9 percent). The laboratory ensures, however, have found significant reductions in alcohol consumption among high-risk patients (four drinks/day for women, six for men
However, it will be always possible to prescribe doses higher than those recommended by the institution of health. “But the doctor becomes responsible for metering and taking a risk in the event of a problem.Whereas, if it conforms to the dosage established by the MSNA, it is responsible in the event of a problem,” complained Bernard Granger.
Ethypharm, the biggest loser ?
Ethypharm, a French laboratory operator baclofen, may be affected by the decision of the recommendation of the MSNA. The pharmaceutical company hopes “to put in the time to market its drug”, that is to say obtain an Authorisation for the placing on the market final. This decision of the MSNA may reduce the possibility of the laboratory to get one, as would create the doubt around the baclofen.
And the temporary Recommendation of use, which the laboratory is funded today, are not satisfied. He has for three years, but this status does not allow him to make the promotion of the drug and distribute it as he wishes. The company has yet much about the democratization of the baclofen to develop its activity, pain and addictions, which represents 41% of its turnover (€228 million in 2016).
In addition, the decision of the health authority of lower dosages risk encumber the revenues of the group from this molecule. It could also push some doctors to prescribe other medications, such as the nalméfène (Selincro) by Lundbeck. This molecule is marketed in France since 2012. But it also criticized “The best, the nalméfène is effective for reducing alcohol consumption”, argued an article of the us scientific journal Plos Medicine, published in 2015. The solutions cost-effective drug, already few in number, seem to be to reduce…
The exorbitant costs of alcohol in France
In addition to being a public health problem, over-consumption of alcohol costs 2.64 billion euros per year to French hospitals, according to the latest figures on the subject of the epidemiological bulletin weekly and the Institut de veille sanitaire. In total, the alcohol would cost 120 billion euros per year to the French company, according to a study funded by the Directorate-general for health and conducted by the French Observatory for drugs and drug addiction.