Alcoholism Pill Completes Phase III Trials in Denmark


2011-07-08 10:30

What if alcoholism could be treated effectively with a simple pill? Such a pill, called nalmefene, just completed phase III trials in Denmark, and the results showed it reduced alcohol consumption by more than 50 percent in people who took the medication during 12-month studies.

Will a pill a day keep the alcohol away?

The potential role of nalmefene in treating alcoholism has been studied for some time. In 2010, a review published in Expert Opinion on Investigational Drugs from the University of Munich explained that the four previous studies of nalmefene published by that time “may indicate a role of this opioid antagonist in the treatment of alcoholism.” The authors noted that ongoing studies would provide additional information concerning its use for alcohol abuse.

The Danish pharmaceutical company Lundbeck has announced the results of such studies it conducted. Its recent phase III clinical trials involved more than 2,000 individuals who had a heavy alcohol dependency. About two-thirds of the participants had never been treated for alcoholism before enrolling in these studies.

The researchers found that alcohol consumption declined significantly after just the first month of treatment. Over the 12-month time frame of the studies, patients had significantly fewer “heavy drinking days,” and total consumption of alcohol declined by more than 50 percent.

Nalmefene reduces the desire to drink excessive amount of alcohol, and reduces the taste for alcohol as well. Researchers noted that nalmefene can be taken daily or on an “as-needed” basis, thus individuals can reduce their alcohol intake rather than stop drinking completely.

In a press statement, Anders Gersel Pedersen, Lundbeck’s director of development, said that “We are pleased that we now have reached a stage with Nalmefene where we can plan the regulatory process with an expected submission of the [EU marketing] application by the end of the year.”

Nalmefene may prove to be helpful in treating other addictions as well, including those associated with opioid use (e.g., codeine, morphine, opium) and addictive behaviors such as gambling. A 2010 study published in the British Journal of Psychiatry reported that 40 mg per day of nalmefene had a significant effect on reducing gambling behavior.

In the United States, three drugs have been approved by the Food and Drug Administration for treatment of alcoholism. Antabuse (disulfiram) makes people sick if they drink alcohol. Naltrexone (Revia) reduces the craving for alcohol and blocks the effects of alcohol in the brain. Acamprosate (Campral) treats some of the withdrawal symptoms alcoholics experience when they stop drinking. Nalmefene, once approved in the United States to treat opioid overdose, was withdrawn from the market.

Because use of nalmefene helps alcoholics reduce their drinking without having to stop completely, its introduction to the market may meet with some resistance, according to Michael Friis Jorgensen, a senior analyst from Alm. Brand Markets, a Danish market research firm, told the Berlingske newspaper that it may be difficult to convince physicians and alcohol treatment professionals that giving alcoholics a pill to curb their drinking may be better than making them stop completely.

However, those of the mind that a significant reduction in drinking is better for one’s health than continuing to drink heavily all the time may find the new pill for alcoholism a welcome addition to the current treatment options. Its eventual availability in the United States is unclear.

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