European patients coping with alcoholism now have a new treatment option. Selincro, or nalmefene, has been approved for the reduction of alcohol consumption in patients with alcohol dependence, and has shipped to markets in Norway, Finland, Poland, and the Baltic countries, according to an announcement this week by the global pharmaceutical company Lundbeck.
“This is an area with significant unmet medical needs, and we are excited about introducing an innovative treatment concept that provides a new and different option for patients who may otherwise not seek treatment,” said Ole Chrintz, Lundbeck's Senior Vice President of International Markets and Europe, in a press release.
Lundbeck reports that during clinical trials, alcoholic patients taking the drug on an as-needed basis reduced their alcohol consumption by about 60 percent after six months of treatment.
While the drug is expected to launch in other countries in 2013 and 2014, there are currently no plans to launch Selincro in the U.S. market “due to the limited data exclusivity that Selincro could get there,” said Lundbeck’s Media Relations Manager Mads Kronborg in an interview with Healthline.
However, if Selincro proves successful in Europe, it's possible that another company could license and distribute it in the U.S., said Roger Meyer, professor of psychiatry at Penn State Hershey Medical Center and founding director of the Alcoholism Research Center at the University of Connecticut Medical School.
Alcoholism: An International Disease
Alcoholism is a disease that affects people in all parts of the world. According to MedlinePlus, about 18 million American adults are alcoholics or have alcohol use issues, and according to the World Health Organization, the European region has the world's highest proportion of illness and premature deaths caused by alcohol abuse.
The four main features of alcoholism, according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) are:
- Craving: a strong need to drink
- Loss of control: not being able to stop drinking once you've started
- Physical dependence: withdrawal symptoms, such as nausea, sweating, or shakiness when you don't drink
- Tolerance: the need to drink greater amounts of alcohol to feel the same level of intoxication
According to the NIAAA, current treatments for alcoholism in the U.S. include talk therapies, such as motivation enhancement therapy and cognitive behavioral therapy.
Medications are also sometimes prescribed along with talk therapy. These include Disulfiram, which interferes with the breakdown of alcohol in the body, and Naltrexone, which blocks the activity of the opiate receptors in the brain responsible for relaying feelings of pleasure when you consume addictive substances.
Selincro and Further Research on Alcohol Dependence
While Selincro is not the first drug developed to help patients who are alcohol dependent cut down on their drinking, it is known as a “universal opioid antagonist” and binds more potently to the Mu opioid receptor in the brain, which is involved in generating feelings of pleasure and reward in response to drug use, Meyer said.
Like other medications used to treat alcohol dependence, Selincro is prescribed in addition to psychosocial therapy and is intended for adult patients who have high-risk drinking habits but don't require immediate detoxification. Drug side effects include nausea, dizziness, insomnia, and headaches.
While doctors can’t yet prescribe Selincro to alcohol-dependent patients in the U.S., Meyer says we badly need a wider variety of medications to combat alcoholism in the States.
“As in the field of depression, where we have too many patients who do not fully respond to their medication, we need new breakthrough medications in addition to the variety of choices that we have among the drug classes that have already been approved,” Meyer said.
According to the NIAAA, alcoholism can last throughout a person’s life, but new research continues to change our understanding of the disease. For example, according to data from the NIAAA’s National Epidemiological Study on Alcohol and Related Conditions, “more than 70 percent of people who develop alcohol dependence have a single episode that lasts on average three or four years.” This survey also shows that “many people who seek formal treatment are able to remain alcohol free, and many others recover without formal treatment.”
If you are concerned about your drinking habits, ask your healthcare provider about medicines and support groups that can help you break the cycle of alcohol dependence.