ESENSE1 is a 24-week efficacy study, and SENSE, a 52-week safety study, were designed to investigate efficacy and safety of 20mg nalmefene taken ‘as needed’ versus placebo in patients with alcohol dependence.
Nalmefene is a small molecule opioid receptor antagonist that inhibits the reward pathway in the brain that reinforces the desire and craving for alcohol and other addictive substances.
H Lundbeck said that the data from both the studies is consistent with the profile of Nalmefene observed in previous clinical studies.
Lundbeck expects to complete a further efficacy study (ESENSE2) in 2Q 2011 and plans to file a marketing authorisation application (MAA) in Europe in 2H 2011, depending on the outcome of the final study.
Biotie CEO Timo Veromaa said that they believe that Nalmefene could significantly transform the treatment of alcohol dependence by providing patients with a real alternative to current abstinence-based therapies.