Biotie’s partner, H Lundbeck A/S, has reported positive results from two Phase III clinical trials (ESENSE1 and SENSE) evaluating nalmefene for the treatment of alcohol dependence.
The results from the two studies revealed that nalmefene is safe and efficacious in helping individuals to lower their alcohol consumption.
ESENSE1, a 24-week efficacy study, and SENSE, a 52-week safety study, were designed to evaluate a 20mg dose of nalmefene taken “as needed” compared to placebo in patients with alcohol dependence.
In both studies, which evaluated around 1,300 patients, the psychosocial intervention involved a brief, standardised programme focused on adherence and follow-up.
Lundbeck is planning to complete a final Phase III trial (ESENSE2) in the second quarter of 2011 and file a marketing authorisation application in Europe in the second half of 2011, based on the final study results.