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20 Jun 2011

Lundbeck to Submit Alcoholism Drug for European Approval

Lundbeck expects to file its alcoholism drug nalmefene in Europe following positive results from the final trial in the drug's Phase III clinical programme.

Danish drugmaker Lundbeck intends to submit alcoholism drug nalmefene for European regulatory approval following the completion of three successful trials.


Lundbeck published a brief summary last week, revealing that nalmefene has 'significant potential' for helping individuals with alcohol dependence.


Unlike existing therapies, nalmefene can be taken with alcohol on an as-needed basis. Other treatments such as disulfiram require full abstinence.


In the final, Phase III trial, 718 individuals in Europe were randomised to receive 20mg of nalmefene or a placebo for 28 weeks.


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