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The U.S. Food and Drug Administration has approved a new medication to treat alcohol dependence and alcoholism that can be injected once a month to reduce craving for those who are trying to stop drinking.

Vivitrol, which is an injectable form of extended-release naltrexone, approved by the FDA last week, could be on the market as soon as June 2006.

Naltrexone has been used for several years to help reduce craving by binding to opioid receptors in the brain, blocking the neurotransmitters that are associated with alcohol dependence.

Until now it has only been available in a pill, which has to be taken daily, which produced problems of patients adhering to the daily-dose routine. The effectiveness of the Vivitrol monthly injections have been shown to last the entire month.

In clinical trials of the new month injection form of the drug, patients who received Vivitrol and psychosocial support experienced greater reduction in days of heavy drinking than those who received only psychosocial support and placebo injection.

Patients who abstained from drinking in the week prior to the treatment with Vivitrol were more likely to maintain complete abstinence over six months and experienced a greater reduction both in drinking days and heavy drinking days.

Vivitrol will be available by prescription and administered by healthcare professionals. It should not be taken by patients who have already experienced liver damage or liver failure.

Vivitrol was developed and manufactured by Alkermes, Inc. It will be marketed in the United States by Cephalon. The company expects sales of the new drug to be between $300 and $500 million annually.

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Comments
April 25, 2006 at 10:02 am
(1) Bob J says:

Naltrexone is a great gift. It is important to remember, however, that recovery is not achieved simply by a cessation of drinking. The text Alcoholics Anonymous does not talk about “not drinking”. It talks about finding a union with a higher source or power. The spiritual path, 12 Steps and community with others is most of the recovery journey. “Drinking is but a symptom”

May 15, 2006 at 2:26 pm
(2) David H. says:

I would agree with Bob J. that naltrexone is a wonderful tool which helps take much of the misery out of the transition to abstinence from alcohol, and thus helps improve the individual’s chances of achieving lasting sobriety. I also believe that sobriety is only the beginning, and that recovery is about what you do INSTEAD of drinking… and thats the part naltrexone can’t do for you. However, I don’t agree with Bob J. that spirituality, a connection with a Higher Power, and working the 12-Steps are absolutely necessary for recovery. Yes, AA works for some people but not for everyone, and there are now other options (such as SMART Recovery) which actually offer better tools for dealing with the various issues and problems of recovery than the AA approach: “turning them over to my HP.”

There is a common misconception most people still have, that “AA is the only way”… and the sooner we dispel that myth and spread the truth to the masses that other options for recovery are available, the better off we’ll ALL be.

July 3, 2008 at 2:11 pm
(3) Cesar C. says:

I found my way here after having my son tell me on my 27th anniversary of sobriety that he would be taking Vivitrol injections in order to “work” on his own problems with alcohol. Well, as one who got sober the traditional (for many but not all) way of finding a new way of living guided by tried and true principles, I’m a bit skeptical about these new fangled methods. However, unlike many BB thumping people in recovery I seem to remember a part of the BB that is specially differential to men of science and basically acknowledges that we don’t know everything about how not to drink only that which has worked for us. I’m giving my son all the space he needs. This is a lonely journey coming out of an addiction and if somebody has discovered something new then by all means try it. If it works then fine, if it doesn’t come to me and I’ll tell you what I did. It’s really about living joyous, happy and free not about the journey.

Cesar C.

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