Posted on 04/13/2006 7:48:09 PM PDT by NormsRevenge
WASHINGTON - A once-a-month injection to treat alcoholism won federal approval Thursday, expanding availability of a drug previously sold only in daily pill form.
The Food and Drug Administration approved Vivitrol, spokeswoman Laura Alvey said. Cambridge, Mass.-based Alkermes Inc. will make the injectable form of the drug, also known as naltrexone. Cephalon Inc., of Frazer, Pa., will market and sell it.
The companies hope monthly injections of the drug, to be administered at a doctor's office, will prove an easier regimen for alcoholics to follow than the daily pill. The drug is to be used in conjunction with counseling or group therapy, the companies said.
"Daily adherence to a medication is challenging for most people, and even more challenging for people with alcoholism," said Richard Pops, Alkermes' chief executive officer.
The drug works by blocking neurotransmitters in the brain believed to be associated with alcohol dependence, diminishing the craving for alcohol.
Pops said the drug's price wouldn't be decided until its U.S. launch in late June. He didn't offer sales predictions and said initial marketing would not include direct-to-consumer advertising.
Naltrexone initially won FDA approval for treating alcoholism in 1994. It first was sold to treat narcotic dependency. Other drugs to treat alcoholism include Antabuse, which has been sold since 1948.
The market for Antabuse and naltrexone has been limited, with annual sales in the low tens of millions of dollars.
Vivitrol will carry the strongest warning prescription drugs can bear. The black-box warning will caution patients that the drug can cause liver damage, said Dr. Elliot Ehrich, Alkermes' vice president. The pill form of the drug bears a similar warning, which says liver damage was observed at higher-than-recommended doses.
Frank Baldino, chairman and chief executive officer of Cephalon, said 2.2 million Americans are seeking treatment for alcoholism, among the 9 million who are alcohol-dependent.
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On the Net:
Food and Drug Administration: http://www.fda.gov/
article is also on net titled as
Injection to Treat Alcoholism OK'd
FDA approves monthly alcoholism injection
I was getting excited. I thought I could start drinking again. Heck I was already imagining my first hangover.
Daily libations could do, but monthly ones are too far apart.
Alcoholics Anonymous® is a fellowship of men and women who share their experience, strength and hope with each other that they may solve their common problem and help others to recover from alcoholism. The only requirement for membership is a desire to stop drinking. There are no dues or fees for AA membership; we are self-supporting through our own contributions. AA is not allied with any sect, denomination, politics, organization or institution; does not wish to engage in any controversy, neither endorses nor opposes any causes. Our primary purpose is to stay sober and help other alcoholics to achieve sobriety.
Well, i am all for any medications that can help people. And there are now several meds to help with the initial withdrawal period for alcoholism,and other drug addictions.
However, if the drug is but a symptom of underlying coping behaviors or attitudes that are dysfunctional, therapy and a 12 step program will make it more powerful and lasting.
Thanks!
Just wondering: Can recovering alcoholics safely drink alcohol-free beer? Or is that too much of a temptation?
No problem. I knew a few guys that couldn't handle/agree with the theology entangled in AA, so they just went back to killing themselves with booze. Shame because there are alternatives to AA that are just as effective.
When I was in the Marines, there was one screwup that was put on antabuse and told don't drink or it could kill ya from an adverse reaction, .
did it stop him from drinking?
No, he got sicker then a dog and finally got booted out.
"...black-box warning will caution patients that the drug can cause liver damage..."
So what's the point?
So what's the point?
Read on:
liver damage was observed at higher-than-recommended doses.
Overdosing on it can cause liver damage. Just like alcohol.
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