Nalmefen (1) – Selincro®
Reduction of alcohol consumption in alcohol dependence
Characteristics
| Start date | 01.09.2014 – Marketing authorisation: 24.02.2013 |
|---|---|
| Resolution | 19.02.2015 |
| INN | Nalmefen |
| Brand name | Selincro® |
| Pharm. company | Lundbeck GmbH |
| G-BA Procedure ID | D-127 |
| ATC code | N07BB05 Drugs used in alcohol dependence (N07BB) |
| ICD-10 codes (AIS) | F10.2Alcohol dependence |
| Alpha-ID codes (AIS) | I13376Alcoholism |
| DDD | 18 mg O |
| Therapeutic area | Mental illnesses Alcohol addiction |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), without physical withdrawal symptoms and who do not require immediate detoxification. Selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption. Selincro should be initiated only in patients who continue to have a high DRL two weeks after initial assessment. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult alcohol-dependent patients whose alcohol consumption is at a high risk level (DRL: drinking risk level), in whom no physical withdrawal symptoms are present and for whom no immediate detoxification is required, provided that the prescription of nalmefen is made in accordance with the prescription restriction in Annex III No. 2 of the Medicinal Products Guideline | Naltrexone |
Studies and Results
|
No. of studies
(best subpopulation) |
4 (12013A 12014A, 12023A, CPH-101-0801) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + ITC (Bucher) |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- On the naltrexone page, the pharmaceutical manufacturer lists seven placebo-controlled studies (Anton 2005, Balldin 2003, Heinälä 2001, Morris 2001, O’Malley 2003, O’Malley 2008, Volpicelli 1997) on the naltrexone page, and the placebo-controlled trials 12013A, 12014A, 12023A and CPH-101-0801 on the nalmefene page.
- The nalmefene studies 12014A, 12023A and CPH-101-0801 had a treatment duration of 24 and 28 weeks respectively, whilst study 12013A had a treatment duration of 52 weeks.
- In all studies, supportive psychosocial therapy was provided in addition to pharmacological treatment.
Patients with alcohol dependence whose alcohol consumption is at a high risk level (DRL: drinking risk level), who do not exhibit physical withdrawal symptoms and for whom immediate detoxification is not required
- The additional benefit of nalmefene compared with the appropriate comparator therapy (naltrexone) is not proven.
- Due to the heterogeneity of the patient populations with regard to the inclusion criteria in the studies and the treatment objectives, the patients in six out of seven naltrexonestudies are not comparable with those in the nalmefene studies who have a high level of alcohol consumption and had not already reduced their consumption following the initial screening.
- In the remaining naltrexone study (Heinälä 2001), naltrexone was not used in accordance with the summary of product characteristics.
- Conclusions regarding the additional benefit of nalmefene compared with the appropriate comparator therapy (naltrexone) cannot therefore be drawn from the indirect comparison presented.
- Overall assessment
- CONCLUSION: Due to the heterogeneity of the patient populations with regard to the inclusion criteria in the studies and the treatment objectives, the patients in six out of seven naltrexonestudies are not comparable with those in the nalmefene studies who had a high level of alcohol consumption and had not already reduced their consumption following the initial screening. In the remaining naltrexone study (Heinälä 2001), naltrexone was not used in accordance with the summary of product characteristics. Conclusions regarding the additional benefit of nalmefene compared with the appropriate comparator therapy (naltrexone) cannot therefore be drawn from the indirect comparison presented. The additional benefit is therefore not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Nalmefen (1) | Selincro® | Lundbeck GmbH | Reduction of alcohol consumption in alcohol dependence | 220,000–248,000 | 100% additional benefit not proven |
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