Selincro, developed by Finland's Biotie Therapies, reduces "alcohol consumption by approximately 60 percent" or about a bottle of wine a day after six months, Danish drugmaker Lundbeck said.
With the go-ahead from the European Commission, Lundbeck, which will manufacture the medication, said it expects to launch Selincro by the middle of this year.
Selincro is mainly aimed at reducing alcohol dependence in adults who drink heavily -- consuming up to six drinks a day -- but who do not suffer from withdrawal symptoms or need detoxification.
"Selincro is thought to reduce the reinforcing effects of alcohol, and thereby reduces the urge to drink alcohol," Lundbeck said.
Lundbeck said excessive alcohol consumption is a world-wide problem, especially in Europe where it said more than 14 million people are dependent on alcohol.