H. Lundbeck A/S (Lundbeck) today announced the results of the clinical phase III programme of Selincro™ (nalmefene), an investigational compound for the treatment of alcohol dependence, at the 20th European Congress of Psychiatry (EPA) in Prague, Czech Republic. The symposium presentation included results from the three placebo-controlled clinical phase III studies (ESENSE 1, ESENSE 2 and SENSE). In addition, the ESENSE 1 study was presented as a poster (poster no. 710) by Prof. Dr. Karl Mann et al. Further details of the ESENSE 2 and SENSE studies will be presented at the Annual Research Society on Alcoholism (RSA) Scientific Meeting in San Francisco in June.
The results of the three studies support the efficacy and tolerability of Selincro in reducing alcohol consumption in patients with alcohol dependence.
"We are very encouraged by these data of Selincro, its efficacy in reducing heavy drinking days and total alcohol consumption combined with a favourable safety and tolerability profile. " says Executive Vice President Anders Gersel Pedersen, Head of Research & Development at Lundbeck, and continues: "We look forward to bringing this important and different medicine through regulatory approval to address this disease which has major consequences for the individual, families and for society at large. "
Summary of the results from phase III program presented at EPA 2012:
All studies were multi-centre, randomized, double-blind, placebo controlled, parallel group studies of 18 mg Selincro taken as needed in patients with alcohol dependence according to DSM-IV criteria. Patients were instructed to take one tablet on each day they perceived a risk of drinking alcohol, preferably one to two hours prior to the anticipated time of drinking. Medical advice and support to enhance motivation and adherence were included in all treatment arms in the studies. No abstinence treatment goal was imposed.
A total of 1,997 patients were randomized in the three studies, 604 patients in ESENSE 1 (298 on placebo, 306 on Selincro), 718 in ESENSE 2 (360 on placebo, 358 on Selincro), and 675 in SENSE (166 on placebo, 509 on Selincro).
The primary objective of the two identical six month studies ESENSE 1 and ESENSE 2 was to evaluate the efficacy of as-needed use of Selincro versus placebo in reducing the number of heavy drinking days (HDD) and the monthly total alcohol consumption (TAC) over a period of six months in alcohol dependent patients. A heavy drinking day is defined as a day with a consumption of at least 60g alcohol for men and at least 40g alcohol for women. The primary objective of SENSE was to evaluate the long-term safety and tolerability of Selincro versus placebo over a period of 52 weeks in patients with alcohol dependence as well as to evaluate the efficacy of Selincro versus placebo at six months.
In all studies a wide range of secondary endpoints were assessed, including the proportion of responders based on drinking measures, alcohol dependence symptoms and clinical status, liver function, other laboratory tests and pharmaco-economic outcomes (not reported here).
In ESENSE 1 and ESENSE 2, Selincro was superior to placebo in reducing the number of HDDs (p <0.05 in both studies) and TAC (ESENSE 1, p <0.05; ESENSE 2, p = 0.088) at Month 6. In SENSE, Selincro was more efficacious than placebo (p<0.05) in reducing the number of HDDs and TAC at the majority of the time points and at the end of the study, although not at Month 6. In all the studies, the effect of Selincro as measured by HDD and TAC was evident already at month one and was maintained throughout the treatment period.
In ESENSE 1, the mean number of HDDs decreased from 19 to 7 days/month and the mean TAC decreased from 84 to 30g/day in the Selincro group at Month 6. In the placebo group, the mean number of HDDs decreased from 20 to 10 days/month and the mean TAC decreased from 85 to 43g/day at Month 6. Further, improvements in the secondary endpoints Clinical Global Impression and the liver enzymes GGT and ALAT were larger (p<0,05) in the nalmefene group than in the placebo group at Month 6.
In ESENSE 2, the mean number of HDDs decreased from 20 to 7 days/month and the mean TAC decreased from 93 to 30g/day in the Selincro group at Month 6. In the placebo group, the mean number of HDDs decreased from 18 to 7 days/month and the mean TAC decreased from 89 to 33g/day at Month 6.
In SENSE, the mean number of HDDs decreased from 15 days/month at baseline to 5 days/month at Month 6 and further to 3 days/month at one year in the Selincro group. While the mean TAC decreased from 75g/day at baseline to 22g/day at Month 6 and to 16g/day at one year. In the placebo group, the mean number of HDDs decreased from 15 days/month at baseline to 6 days/month at Month 6, while the mean TAC decreased from 75g/day at baseline to 27g/day at Month 6, with essentially no further decreases for both endpoints at one year.
In all three clinical studies the overall safety profile of Selincro was consistent with observations and data provided in previous studies, resulting in a total clinical database of more than 3,000 individuals. The most frequent adverse events included dizziness, insomnia and nausea and were mild and transient. The majority of these events had an onset within the first days after the first dose and decreased with treatment continuation.
About Selincro™ (nalmefene)
Selincro is an opioid system modulator with a distinct mu (µ), delta (δ), and kappa (κ) profile. With its modulating effect on the cortico-mesolimbic system, Selincro is thought to reduce the reinforcing effects of alcohol, helping the patient to reduce drinking.
Lundbeck licensed the rights to Selincro from Biotie Therapeutics Corp. (Biotie) in Finland. Under the terms of the agreement, Biotie received an execution fee of EUR 12 million. In total, Biotie is eligible for up to EUR 84 million in upfront and milestone payments plus royalty on sales. Lundbeck will be responsible for manufacturing and registration of the product.
Lundbeck holds the global rights to the compound.
Lundbeck has submitted a European Marketing Authorisation Application (MAA) for nalmefene for the treatment of alcohol dependence via the centralised procedure for regulatory approval in Europe in December 2011.
About alcohol dependence
Alcohol dependence is comparable to other chronic diseases such as diabetes, asthma and hypertension in terms of vulnerability, onset and course.2 In Europe more than 15 million people suffer from alcohol dependence in any one year.3 Alcohol consumption is the second-highest risk factor for ill-health in Europe, after tobacco, and is strongly correlated with the risk of short-and long-term morbidity and mortality.4,5,6
The standard treatment for alcohol dependence consists of psychosocial therapy or pharmacological intervention in combination with psychosocial therapy to achieve and maintain abstinence,7 but the abstinence approach shows relapse rates as high as 80%.8,9 High failure rates have led to research into an alternative, reduction based approach. Reduction of alcohol consumption is associated with rapid improvements in short-term health status and reduced risk of long-term illness and reduction of alcohol consumption decreases the risk of morbidity and mortality in patients with alcohol dependence.4,10,11
About The European Psychiatric Association
The European Psychiatric Association is considered the largest international association of psychiatrists in Europe with active members in as many as 75 countries. Among its members stand leading experts in numerous fields covering the interests of psychiatrists in academia, research and practice.
The content of this release will have no influence on the Lundbeck Group's financial guidance for 2012 which was provided on 8 February 2012 in connection with the release of the financial results for 2011.
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H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company highly committed to improving the quality of life for people suffering from brain disorders. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company's products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy and Huntington's, Alzheimer's and Parkinson's diseases.
Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today Lundbeck employs approximately 6,000 people worldwide. Lundbeck is one of the world's leading pharmaceutical companies working with brain disorders. In 2011, the company's revenue was DKK 16.0 billion (approximately EUR 2.2 billion or USD 3.0 billion). For more information, please visit www.lundbeck.com.