Date: 2011-01-03
Type of information:
phase: 3
Announcement: completion of the study
Company: Lundbeck (Denmark)
Product: Nalmefene
Action mechanism: Nalmefene is a selective opioid receptor ligand with antagonist activity at mu and delta opioid receptors and partial agonistic activity at the kappa opioid receptor. This pharmacological profile helps to control and reduce alcohol intake.
Disease: alcohol dependence
Therapeutic area: CNS diseases
Country: Europe
Trial
details: Based on the results of earlier trials, Lundbeck has initiated three phase III trials in Europe enrolling approximately 2,000 patients randomised into two groups receiving nalmefene (20 mg as needed, orally) and placebo, respectively. Two of the three trials (ESENSE1 and ESENSE2), in which patients were treated over a period of six months, primarily aimed to demonstrate the efficacy of nalmefene, whilst the primary objective of the third study (SENSE), in which patients are treated for 12 months, is to confirm the safety and tolerability of the compound.
Latest
news: Lundbeck announced that it has completed a short-term efficacy study and a long-term safety study in the overall pivotal programme with nalmefene (ESENSE1 and SENSE). The studies were conducted in Europe and enrolled about 1,300 patients with alcohol dependence. A concomitant psychosocial intervention in the studies was a brief, standardised programme focussed on adherence and follow-up. No abstinence treatment goals were imposed.
In both studies the overall safety profile of nalmefene was consistent with observations and data provided in previous studies. The most frequent adverse events included dizziness, insomnia and nausea.The company expects to complete the third and final phase III study (ESENSE 2) in the second quarter of 2011. Nalmefene is on track for submission of the MAA in Europe in the second half of 2011 pending successful completion of the last pivotal efficacy study.
