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Published on 10 April 2013

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New data on Selincro

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H. Lundbeck A/S (Lundbeck) has announced 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 six months of 57% in study 1 (ESENSE 1)(1) and 62% in study 2 (ESENSE 2),(2) and after 12 months of 67% in study 3 (SENSE).(3) The analyses from these randomised, double-blind, placebo-controlled Phase III studies were presented at the 21st European Congress of Psychiatry (EPA) in Nice, France.
“The clinical data in patients with alcohol dependence with a high risk drinking level are very robust and consistent across the three studies,” said Executive Vice President Anders Gersel Pedersen, Head of Research & Development at Lundbeck. “As the first medicine approved for the reduction of alcohol consumption, Selincro provides a new and innovative option for patients who may otherwise not seek treatment.”
Selincro is thought to reduce the reinforcing effects of alcohol, and thereby reduces the urge to drink alcohol.(7,8) Selincro is a unique dual-acting opioid system modulator(9,10) and works on the brain’s motivational system, which is dysregulated in patients with alcohol dependence.(11) Lundbeck will provide Selincro as part of a novel treatment concept and it includes continuous psychosocial support focused on the reduction of alcohol consumption and treatment adherence. It has been developed for use on an as-needed basis, taken on days when the patient feels a risk of drinking.(12)
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.(1,2,3)
  • 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 44g/day which is equivalent to a 57% reduction.(1)
  • 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.(2)
  • 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 six months and after 12 months the total alcohol consumption decreased to 33g/day which is equivalent to a 67% reduction.(3)
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 six 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.(1,2,3)
“To stop drinking completely is not an achievable or acceptable goal for many patients with alcohol dependence, and therefore Selincro is an important addition to the current treatment options which aim to support sustained abstinence,” commented Wim van den Brink, MD PhD from the Institute for Addiction Research at the University of Amsterdam, Netherlands. “The reduction of alcohol consumption supported by Selincro may have benefits not only for patients and their families, but also at their workplace and for society as a whole.”
Alcohol dependence is a medical and behavioural disorder with a high probability of a chronic, relapsing and progressive course.(13,14) There is a significant unmet need as alcohol dependence is both underdiagnosed and undertreated. In Europe more than 90% of the 14 million patients with alcohol dependence are currently untreated.(5,6)
Selincro was approved by the European Commision for the reduction of alcohol consumption in patients with alcohol dependence on the 25th of February 2013, and Lundbeck expects to launch Selincro in its first markets in Q2-2013.
About Selincro® (nalmefene)
Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high risk drinking level (>60g/day for men, >40g/day for women) without physical withdrawal symptoms and who do not require immediate detoxification. Selincro should be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and the reduction of alcohol consumption.
Treatment should be initiated only in patients who continue to have a high risk drinking level two weeks after an initial assessment. Selincro is to be taken as-needed; that is, on days the patient perceives a risk of drinking alcohol, maximum one tablet should be taken, preferably 1-2 hours prior to the anticipated time of drinking. In the clinical trials Selincro was taken on approximately half of the days.(12)
References:
  1. Van den Brink et al. Poster no. 1107 presented at the 21st European Congress of Psychiatry, Nice, France, 6-9 April 2013. Esense 1 – randomised controlled 6-month study of as-needed nalmefene: subgroup analysis of alcohol dependent patients with high drinking risk level. Available at: http://epa.ekonnect.co/swf/poster_viewer.aspx
  2. Van den Brink et al. Poster no. 1108 presented at the 21st European Congress of Psychiatry, Nice, France, 6-9 April 2013. Esense 2 – randomised controlled 6-month study of as-needed nalmefene: subgroup analysis of alcohol dependent patients with high drinking risk level. Available at: http://epa.ekonnect.co/swf/poster_viewer.aspx
  3. Van den Brink et al. Poster no. 1105 presented at the 21st European Congress of Psychiatry, Nice, France, 6-9 April 2013. Long-term efficacy of nalmefene as-needed in alcohol dependent patients with high drinking risk levels: Results of a subgroup analysis. Available at: http://epa.ekonnect.co/swf/poster_viewer.aspx
  4. Mann et al. Epub ahead of print, dec 2012, Biol Psychiatry. http://dx.doi.org/10.1016/j.biopsych.2012.10.020
  5. Kohn et al. Bull World Health Organ 2004; 82(11):858-866
  6. Wittchen et al. Eur Neuropsychopharmacol 2011;21(9): 655-679
  7. Spanagel & Valentina. Curr Topics Behav Neurosci 2013; 13:583–609
  8. Drobes et al. Alcohol Clin Exp Res 2004; 28(9):1362-70
  9. Michel et al. Meth Find Exp Clin Pharmacol 1985; 7:175-177
  10. Hillemacher et al. Expert Opin. Investig. Drugs 2011; 20(8): 1073-1086
  11. Heinz et al. Addict Biol 2009; 14(1): 108-118
  12. Selincro, Summary of product characteristics (SMPC). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002583/WC500140255.pdf
  13. Burge et al. Am Fam Physician 1999; 59(2): 361-370
  14. Leshner. Science 1997; 278:45-47


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