Nalmefene proven to work in studies

[YouKayBee]

Nalmefene is a drug which is similar to Naltrexone, but with greater bioavailability and longer half life.

Lundbeck receives positive opinion for approval of Selincro (nalmefene) in the European Union Copenhagen Stock Exchange:LUN

Nalmefene - Wikipedia, the free encyclopedia

Lundbeck has been doing some research and he found heavy drinkers who used Nalmefene reduced their drinking in the first month by more than 40%, and after 6-12 months by more than 60%. His subjects were drinking on average 10.5 units a day at the start of the studies.

The new drug is actually registered as Selincro, it's thought it'll be more expensive than Naltrexone but at last something which is being recognised. From the wikipedia entry it looks as if the dosing might be half that of that recommended for Naltrexone which might negate any extra cost.

I know quite a few people think Naltrexone and TSM type treatment (which this is)is only for those who wish to continue drinking. Many people who have found success with TSM actually were at their wits end, their goal wasn't to drink or not drink it was to solve the problems alcohol was causing. In my case the last thing I wanted to do was drink, but I did want to get rid of the incontrollable urges to drink, and stop making such a mess of my life via alcohol. I was so desperate I would consider a 'drinking' option if it would solve the problem and it did.

[Lo0p]

Nalmefene proven to work in studies

Sinclair always knew it was a superior drug for the application.

[YouKayBee]

Nalmefene proven to work in studies

Lo0p;1429890 wrote: Sinclair always knew it was a superior drug for the application.

I'll be asking my GP about this and hopefully getting on prescription when or if it becomes available. Unless they don't think I need it, or I could be their guinea pig!:H

[lostsole]

Nalmefene proven to work in studies

Very interesting! Hope it goes generic quickly for those in the US that will want it.

[YouKayBee]

Nalmefene proven to work in studies

lostsole;1430361 wrote: Very interesting! Hope it goes generic quickly for those in the US that will want it.

I think there's a standard number of years which have to pass for that to happen?

[Colin]

Nalmefene proven to work in studies

Ukblonde;1429889 wrote:
Lundbeck receives positive opinion for approval of Selincro (nalmefene) in the European Union Copenhagen Stock Exchange:LUN

Nalmefene - Wikipedia, the free encyclopedia

From the wikipedia entry:-

Nalmefene (Revex), originally known as nalmetrene, is an opioid receptor antagonist developed in the early 1970s,[1] and used primarily in the management of alcohol dependence, and also has been investigated for the treatment of other addictions such as pathological gambling and addiction to shopping.

From the Lundbeck press release:-

Lundbeck holds the global rights to the compound and is responsible for the registration, manufacturing and marketing of the product.

Do we have a patent lawyer on board? Why is this any different from trying to establish global rights to the compound sodium chloride? I'm missing something.

[lostsole]

Nalmefene proven to work in studies

Tough to say. I don't know the laws around the patents and such. If it has been around that long and was known for treating AL disorders why now? Baclofen makes sense since it was not tied to that use at all until recently.

Something sounds really odd. Dunno.

[YouKayBee]

Nalmefene proven to work in studies

lostsole;1430512 wrote: Tough to say. I don't know the laws around the patents and such. If it has been around that long and was known for treating AL disorders why now? Baclofen makes sense since it was not tied to that use at all until recently.

Something sounds really odd. Dunno.

Is is something to do with the fact no one has actually gained approval or licence for it's use in this way?For instance Naltrexone still isn't licensed for use to treat alcoholism in the UK.

[Heavy Fuel]

Nalmefene proven to work in studies

The issue with many drugs is what the "label uses" actually are. Prescribing the drug for any other purpose is considered "off label" and opens the prescribing doctor to more liability. When a drug is submitted to the FDA, part of the process involves establishing the drug works for a disease or condition. The actual on label use of naltrexone is "craving reduction." From some of the initial studies, there is a warning naltrexone may cause liver damage, which is true, at 6 times the recommended dosage. We will have to see what the approval of nalmefene holds.

TSM worked very well for me. I took it on blind faith with one truly applicable study and Dr. Eskapa's book. The approval of this drug will require TSM be further studied with the drug and will put to rest many objections of "traditional" doctors. There is a misconception in medicine that to be effective, the treatment should immediately stop the substance abuse. With a TSM type model, the idea is harm reduction, not abstinence.

But this is a step in the right direction!

[Colin]

Nalmefene proven to work in studies

Ukblonde;1430741 wrote: Is is something to do with the fact no one has actually gained approval or licence for it's use in this way?For instance Naltrexone still isn't licensed for use to treat alcoholism in the UK.

That could easily be the explanation. Baclofen has long been approved for large doses for MS etc. and much is known about it due to the long history. Doctors can therefore easily prescribe baclofen off-label to treat alcoholism.

Nothing much is known about the primary effects, safety and side-effects of nalmefene, so doctors are justifiably nervous about prescribing it.

The generic drug companies will only manufacture nalmefene if there is a large enough market and a handful of MWOers is unlikely to be a large market. It still seems attractive compared to naltrexone so ... Lobbying via Sinclair's TSM?

[Ne/Neva Eva]

Nalmefene proven to work in studies

When there is a new application for a generic drug, the new application can be trademarked/patented so that the generic version may not be sold/used for the specific purpose. The same is true for the creation of an extended release version, though it's a bit different and I don't remember exactly how. (Maybe number of years that the patent/trademark exists?)

Bupropion is an example. The generic is generic. When it is used for smoking cessation it is prescribed and sold as Zyban, which is still under patent/trademark. (I don't remember which applies in this situation.) When prescribed Zyban the cost was more than $100/month. It comes packaged with steps for smoking cessation, but is the exact same drug as generic bupropion. I can get generic bupropion covered by insurance for $10/month. I had my physician change the purpose for the prescription.

The laws vary by country, obviously. What may be generic, or off patent, in the EU may still be patented in the U.S. This is true of a drug used to treat narcolepsy/somnolence. When I tried to get it here, my insurance company balked at the $1200/mo cost. When I got it from an online pharmacy it was about $80/mo. Including shipping.

[nancy]

Nalmefene proven to work in studies

patents

Are weak for nalmefene in the U.S. That's why they aren't marketing it in the U.S.

[spiritwolf333]

Nalmefene proven to work in studies

Ukblonde;1429889 wrote: Nalmefene is a drug which is similar to Naltrexone, but with greater bioavailability and longer half life.

Lundbeck receives positive opinion for approval of Selincro (nalmefene) in the European Union Copenhagen Stock Exchange:LUN

Nalmefene - Wikipedia, the free encyclopedia

Lundbeck has been doing some research and he found heavy drinkers who used Nalmefene reduced their drinking in the first month by more than 40%, and after 6-12 months by more than 60%. His subjects were drinking on average 10.5 units a day at the start of the studies.

The new drug is actually registered as Selincro, it's thought it'll be more expensive than Naltrexone but at last something which is being recognised. From the wikipedia entry it looks as if the dosing might be half that of that recommended for Naltrexone which might negate any extra cost.

I know quite a few people think Naltrexone and TSM type treatment (which this is)is only for those who wish to continue drinking. Many people who have found success with TSM actually were at their wits end, their goal wasn't to drink or not drink it was to solve the problems alcohol was causing. In my case the last thing I wanted to do was drink, but I did want to get rid of the incontrollable urges to drink, and stop making such a mess of my life via alcohol. I was so desperate I would consider a 'drinking' option if it would solve the problem and it did.

Bump

[spiritwolf333]

Nalmefene proven to work in studies

April 12-2013 A potential new treatment for alcoholism called nalmefene is effective and safe for reducing alcohol consumption in alcohol dependent individuals, says a new study published this week in Biological Psychiatry.

[COSGringo]

Nalmefene proven to work in studies

spiritwolf333;1522751 wrote: April 12-2013 A potential new treatment for alcoholism called nalmefene is effective and safe for reducing alcohol consumption in alcohol dependent individuals, says a new study published this week in Biological Psychiatry.

I as are others, are interested. Thanks.