H. Lundbeck A/S — Selincro EMA EPAR public assessment report (EMEA/H/C/002583, 2013)
H. Lundbeck A/S · 2013 · EMA EPAR public assessment report · company profile →
Report summary
The European Medicines Agency (EMA) assessed Selincro (nalmefene) for reducing alcohol consumption in alcohol-dependent adults. H. Lundbeck A/S submitted the Marketing Authorisation Application in November 2011, receiving a positive CHMP opinion in December 2012. Nalmefene, an opioid receptor modulator, demonstrated rapid absorption and high receptor occupancy. Clinical trials showed statistically significant, though small and inconsistent, reductions in Heavy Drinking Days (HDDs) and Total Alcohol Consumption (TAC) compared to placebo. A more pronounced effect was observed in patients with high or very high drinking risk levels. Common adverse events included dizziness, nausea, and insomnia, leading to withdrawal, but no major safety concerns were identified over one year. The CHMP recommended marketing authorization for this specific subgroup, acknowledging the overall small treatment effect but favorable benefit-risk balance.
Key findings — cited to the page
| Nalmefene hydrochloride content | 20 mg | Selincro · p.7 |
| Number of randomized patients | 604 | Study 12014A · p.39 |
| Nalmefene tablet strength | 18 mg | Selincro · p.7 |
| Nalmefene hydrochloride dihydrate content | 21.917 mg | Selincro · p.7 |
| Mean difference to placebo in monthly number of HDDs | -1.7 days/month | Study 12023A · p.46 |
| Nalmefene base content | 18.06 mg | Selincro · p.7 |
| Subjects with sleep-related symptoms at both night- and day-time | 4.9% | · p.57 |
| Recommended indication by CHMP | 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. Selincro should only be prescribed in conjunction with continuous psychosocial support focussed on treatment adherence and reducing alcohol consumption. Selincro should be initiated only in patients who continue to have a high drinking risk level two weeks after initial assessment. | Selincro · p.8 |
| Marketing Authorisation Application submission date | 25 November 2011 | Selincro · Europe · p.5 |
| CHMP positive opinion date | 13 December 2012 | Selincro · Europe · p.7 |
| Proposed indication | reduction of alcohol consumption in patients with alcohol dependence | Selincro · p.5 |
| Number of randomized patients | 718 | Study 12023A · p.39 |
Source: H. Lundbeck A/S ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →