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France – After being launched on June 15 and then withdrawn from the market, the drug Baclocur® (baclofen) from the Ethypharm laboratory, indicated in the treatment of alcohol dependence, is again available for doctors and their patients [1].
Baclofen history is definitely not a long, quiet river. Recall that the announcement of its launch on June 15, replacing the RTU, was abruptly interrupted by the legal action of the Baclohelp patient group who feared that baclofen could no longer be prescribed at doses other than those set by the AG that they set a limit of 80 mg per day – an injurious ceiling for patients according to the association and a number of prescribers (Read Federation Addiction: “resume baclofen file openly and dispassionately”).
In a new twist in the saga, Ethypharm informs in a press release of the release of L the Baclocur® 10, 20, 30 and 40 mg range in pharmacies and hospital pharmacies, following a decision by the State Council, referred this summer to the National Agency for the Safety of Medicines (ANSM) (see box).
The French laboratory warns, however, that it will take a few weeks for its products to be available again.
“We are satisfied with this decision. The supply of the Baclocur® range, a product developed specifically in alcohol addiction, offers a new alternative to the care of patients who wish to reduce their alcohol consumption “he said. Bertrand deluard, President and CEO of Ethypharm [1].
It should be noted that in its decision made on Wednesday, the State Council notes that, under certain conditions, “a pharmaceutical specialty may be subject to a prescription that does not comply with its marketing authorization”. Implied beyond the limit of 80 mg / day.
Will this decision lead all parties to an agreement? “I am quite satisfied despite everything, even if it is a defeat,” he told Agence France-Presse (AFP). Thomas Maës-Martin, president of the “Baclohelp” collective, which is now awaiting the merits of the case by the administrative court of Cergy-Pontoise.
ANSM and Baclofen: the saga
October 2018
ANSM grants marketing authorization for BACLOCUR® specialty in the treatment of alcohol-dependent patients at the maximum dose of 80 mg / day, after taking into account the views of both authorities and taking into account the available data until today.
June 15, 2020
Ethypharm markets Baclocur® in the form of divisible tablets of 10, 20, 30 and 40 mg, ending the temporary recommendation for use (RTU) for (Lioresal 10 mg and Baclofen Zentiva 10 mg), two other baclofen-based specialties does not have a marketing authorization but can legally be used for this indication.
June 17, 2020
Two days later, its marketing authorization was suspended by the administrative court of Cergy-Pontoise, seized by the BacloHelp and Aubes associations. All Baclocur strengths are withdrawn from the market pending a decision on the substance. The National Agency for the Safety of Medicines (ANSM) immediately appeals to the State Council.
July 30, 2020
Ethypharm’s application for interim measures is rejected
25 November 2020
The Council of State reverses the decision taken by the Cergy-Pontoise Administrative Court.
November 26, 2020
Ethypharm announces the commercialization of its BACLOCUR® specialties
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