Selincro(nalmefene)

Selincro (nalmefene) is a new active substance indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level, without physical withdrawal symptoms and who do not require immediate detoxification. It should be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption, and initiated only in patients who continue to have a high drinking risk level two weeks after initial assessment. The Marketing Authorisation Application was submitted on 25 November 2011, and a positive opinion from the CHMP was issued on 13 December 2012, recommending the granting of marketing authorisation. A contraindication for Selincro is severe renal or severe hepatic impairment.

Efficacy findings include a mean difference to placebo in monthly number of heavy drinking days (HDDs) of -1.7 days/month and -2.3 days/month. The change from baseline in monthly number of HDDs was -11.2 days/month, compared to -8.9 days/month for placebo. The change from baseline in total alcohol consumption (TAC) was -50.7 g/day, compared to -39.7 g/day for placebo, with a mean difference to placebo in TAC of -11 g/day. In one study, 37% of patients were RSDRL responders, compared to 44% for placebo, with an odds ratio for RSDRL response of 0.70.

Safety data indicates that 4.9% of subjects experienced sleep-related symptoms at both night- and day-time. The proportion of patients who withdrew from treatment in the nalmefene group was 42.9% in one study and 48% in another, compared to 33.9% and 26% for the placebo groups, respectively. Withdrawal of consent was 15.7% in the nalmefene group versus 13.3% in the placebo group.