Nalmefen (1) – Selincro®

• 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.