Lundbeck completes alcohol dependence drug Phase 3 clinical study
Lundbeck, a licensing partner of Biotie Therapies, has completed ESENSE2, the last study in its Phase 3 program which evaluates nalmefene for the treatment of alcohol dependence.
Results from this 718 patient, double-blind, placebo controlled trial were consistent with the profile observed in previous clinical studies of nalmefene.
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.
Based on the results of previous trials sponsored by Biotie, Lundbeck initiated three Phase 3 clinical studies in Europe enrolling 2,000 individuals randomized into two groups receiving nalmefene (20 mg as needed, orally) or placebo, in addition to a medical compliance program.
Two of the three trials (ESENSE1 and ESENSE2), in which individuals were treated over a period of six months, were primarily aimed to demonstrate the efficacy of nalmefene, whilst the third study (SENSE), in which individuals were treated for 12 months, was conducted to confirm the safety and tolerability of the compound.
Biotie president and CEO Timo Veromaao said Nalmefene is the treatment that has been developed to help patients reduce their harmful levels of alcohol consumption, therefore offering patients, physicians and payors a treatment option.
Lundbeck plans to file a marketing authorization application (MAA) in Europe by the end of 2011.