Nalmefene: Phase III data

Pooled data from 3 double-blind, placebo-controlled, European Phase III trials in about 2,000 patients showed that oral nalmefene led to a >=50% reduction in heavy drinking days, defined as >=5 drinks/day for men and >=4 drinks/day for women, from baseline after 6 months of treatment. Furthermore, data from the 12-month safety Phase III SENSE trial in about 650 patients showed that the treatment effect was maintained after 1 year of treatment. The partners also said that some undisclosed endpoints were not statistically significant at every time point. Details were not disclosed.

The 6-month efficacy Phase III ESENSE2 and ESENSE1 trials, in which the co-primary endpoints were the change from baseline in monthly number of heavy drinking days and total alcohol consumption, enrolled 718 and about 650 patients, respectively. Patients with alcohol dependence received 20 mg nalmefene or placebo as needed for the duration of each of the 3 trials. The most common adverse events were dizziness, insomnia and nausea. Lundbeck said it will present efficacy and safety data at scientific meetings during the next 12 months, with an MAA submission planned for year end. ...