Strong Ph III results for Lundbeck alcohol dependence drug Selincro

Danish CNS drug specialist Lundbeck (LUN DC) announced positive results of a Phase III clinical program of Selincro (nalmefene), an investigational compound for the treatment of alcohol dependence, at the 20th European Congress of Psychiatry (EPA) in Prague, Czech Republic.

Patients given nalmefene reported a 64%-79% drop in total alcohol intake, compared with 49%-64% for those on placebo, The drug, licensed from Finland’s Biotie Therapies, has already been submitted for European approval (The Pharma Letter December 22, 2011), with a decision expected at the beginning of next year. .

The symposium presentation included results from the three placebo-controlled Phase III studies (ESENSE 1, ESENSE 2 and SENSE). In addition, the ESENSE 1 study was presented as a poster (poster no. 710) by Karl Mann et al. Further details of the ESENSE 2 and SENSE studies will be presented at the Annual Research Society on Alcoholism (RSA) Scientific Meeting in San Francisco in June. The results of the three studies support the efficacy and tolerability of Selincro in reducing alcohol consumption in patients with alcohol dependence.