Date: 2013-04-08
Type of information:
phase: 3
Announcement: results
Company: Lundbeck (Denmark)
Product: Selincro®
Action mechanism: Nalmefene is a selective opioid receptor ligand with antagonist activity at mu and delta opioid receptors and partial agonistic activity at the kappa opioid receptor. This pharmacological profile helps to control and reduce alcohol intake.
Disease: alcohol dependence
Therapeutic area: CNS diseases
Country:
Trial details:
Latest
news: * On April 8, 2013, Lundbeck has presented the results of the revised analysis of the Phase III programme that formed the basis for the approval of Selincro® (nalmefene) in the EU on February 25, 2013. Alcohol dependent patients with high risk drinking level (>60g/day for men, >40g/day for women) treated with Selincro showed a significant reduction in total alcohol consumption after 6 months of 57% in study 1 (ESENSE 1) and 62% in study 2 (ESENSE 2), and after 12 months of 67% in study 3 (SENSE).3 The analyses from these randomized, double-blind, placebo-controlled Phase III studies were presented at the 21st European Congress of Psychiatry (EPA) in Nice, France.
The presented results are from a subgroup analysis in approximately 850 patients who continued to have a high risk drinking level after an initial assessment in the three pivotal clinical trials ESENSE 1, ESENSE 2 and SENSE.
• In ESENSE 1 the patients enrolled in the study with a high risk drinking level drank on average 102 grams of alcohol (equivalent to approximately 1.5 bottles of wine) per day. Patients treated with Selincro showed a 40% reduction in total alcohol consumption within the first month, and after 6 months the total alcohol consumption decreased to 44 g/day which is equivalent to a 57% reduction.
• In ESENSE 2 the patients enrolled in the study with a high risk drinking level drank on average 113 grams of alcohol per day. Patients treated with Selincro showed a 49% reduction in total alcohol consumption within the first month, and after 6 months the total alcohol consumption decreased to 43 g/day which is equivalent to a 62% reduction.
• In SENSE the patients enrolled in the study with a high risk drinking level drank on average 100 grams of alcohol per day. Patients treated with Selincro showed a 36% reduction in total alcohol consumption within the first month, 56% after 6 months and after 12 months the total alcohol consumption decreased to 33 g/day which is equivalent to a 67% reduction.
All three studies showed a consistent reduction in alcohol consumption, and Selincro was superior to placebo at study end in all three trials. The two identical 6-months studies showed that patients treated with Selincro on average reduced their total alcohol consumption by more than 40% within the first month and by approximately 60% after 6 months, and this was statistically significant from placebo. In addition, data from the 1-year study confirmed that the positive effects of Selincro are maintained and even improved after one year of treatment, leading to a 67% reduction in total alcohol consumption – equivalent to nearly one bottle of wine per day. In all three studies Selincro was generally well tolerated, and adverse events were mostly mild to moderate and transient.
