Baclofen given a Marketing Authorisation in France

[Otter]

Well, at long last the French drug agency has given a marketing authorisation for baclofen use in alcoholism. This happened on Oct. 23 2018 and was granted to a company called Ethypharm.

The authorisation is for up to 80 mg a day but it's possible to go above that on an off-licence basis. This is the first MA for baclofen anywhere in the world. An MA allows for advertising of the drug for baclofen so, in France, it can be advertised to the public on TV and in newspapers etc. That's a really important step because the problem has always been that people just didn't know about the drug, so could not benefit.

There is obviously a concern by baclofen advocates that the level of prescription is very low and there have been a number of critical papers written about the decision to limit it to 80mg a day.

More to follow, but it's an important and significant development. The arguments for and against this development are flying around. All very interesting.

[Otter]

Re: Baclofen given a Marketing Authorisation in France

i forgot to post a link to the announcement in the press.osteroops:

Here it is: Alcohol-related Disorders: Ethypharm Is Granted Marketing Authorisation for Its Drug Baclocur(R)

[Otter]

Re: Baclofen given a Marketing Authorisation in France

Oh, yeah, and I also forgot to mention that the Marketing Authority is now mentioned on Wikipedia's Alcoholism page.

Alcoholism - Wikipedia

Which is good thing because when you google anything the Wiki entry always seems to come up first.

By way of background, the French national drugs agency, the ANSM, decided in 2017 to limit baclofen use to 80 mg per day after a report came out that baclofen was associated with more deaths and hospitalisations than other drugs for alcoholism. There was a huge outcry among baclofen users about this and a legal challenge was launched to try to overturn the decision, which challenge failed. However, at the same time, the government clarified the position and issued a statement that people could continue to use high doses of baclofen and that there would be futher investigation into the use of baclofen at high doses, so it's not over yet.

The real issue, at the moment, is that only doses up to 80 mg per day are paid for by state medical insurance, so anything above that has to be paid for by the patient. I don't think this is a huge problem since baclofen is initially started while still drinking and my experience is that a heavy-drinking alcoholic starting on baclofen treatment is going to do two things; 1. miss a lot of doses and accumulate a lot of baclofen and 2. lie about it. The result is that the doctor continues to prescribe and increase the dose while the alcoholic patient accumulates a basketful of baclofen.

The problem with the situation in France is that the ANSM reacted to a report which found that there were more deaths and hospital admissions "associated" with baclofen use than associated with Naltrexone, Nalmafene or Campral. It didn't find that baclofen actually caused a single death or hosptial admission.

What I find incredible is that it still hasn't got through to researchers or almost anyone that the fact that baclofen works at all suggests that it is working on a part of the brain which these other drugs don't work on. And, they are used by a different cohort of patients. Campral is only supposed to be used for abstinence, in patients who are not drinking at all. So why would there be any reason to compare the two drugs? Both Nal drugs work as antagonists, not agonists, and on a different set of neuro receptors and are supposed to be taken before drinking. For those who take baclofen, all other treatments are supposed to have failed, and many baclofen users are taking 1 to 2 litres of hard spirits a day, which means they are always intoxicated and many start drinking the moment they wake up in the morning.

The study should have compared "like" drugs and the like drug for baclofen is alcohol itself. What percentage of people drinking a litre or more of spirits a day die or are hospitalised over a period of a year? That's what should have been compared to problems with baclofen users.

Anyway, it's still early days in all of this but at least there is movement. A few years ago I tried to amend the alcoholism page of Wiki and met huge resistance and there is, or will be, this year at least one country, France, where baclofen will be advertised and marketed as a cure/treatment for alcoholism and that can only go one way, forward.

It's just sad it's taken so long and there's been such fierce and unreasoned objection to some people with a such a serious and life-threatening illness, being able to take the medication of their choice.

[Otter]

Re: Baclofen given a Marketing Authorisation in France

New Paper:The Use of Baclofen as a Treatment for Alcohol Use Disorder: A Clinical Practice Perspective

The Use of Baclofen as a Treatment for Alcohol Use Disorder: A Clinical Practice Perspective (click to read)

Frontiers in Psychiatry has just published a new paper on baclofen in the treatment of alcoholism written by pre-eminent authorities on the subject. The authors of the paper review the use of baclofen in treatment disorder and the evidence in support of its use and best practice in the prescription of baclofen concluding that it is a promising medication in treating moderate to severe AUD.