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H. Lundbeck A/S (Lundbeck) today announced the completion of the final study (ESENSE2) in the phase III clinical programme for nalmefene in patients with alcohol dependence. In this multi-centre, double-blind, placebo-controlled study, 718 individuals were randomised to receive oral administration of 20mg of nalmefene or placebo on an as-needed basis for a total of 28 weeks of treatment.
“We are pleased that we now have reached a stage with nalmefene where we can plan the regulatory process with an expected submission of the MAA towards the end of the year” said Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck. He said: “Across the clinical phase III programme consistency and robustness were observed and the studies support the overall positive clinical profile of nalmefene.”
During the clinical programme a wide range of primary and secondary endpoints were assessed, including number of heavy drinking days per month (HDD), total alcohol consumption in grams per day (TAC), proportion of responders based on drinking measures, alcohol dependence symptoms and clinical status, liver function and other laboratory tests, pharmaco-economic outcomes and treatment discontinuation effects. All assessments were consistently in favour of nalmefene compared to placebo, though some were not statistically significant at every single time point. It was consistently observed that the medical intervention with nalmefene had a strong effect that was seen within the first month and led to a reduction in alcohol consumption of over 50% and was maintained throughout the study periods.
The three studies in the overall phase III clinical programme were conducted in Europe and enrolled about 2,000 individuals with alcohol dependence. A medical compliance encouragement programme was included in all treatment arms in the studies. No abstinence treatment goals were imposed. The data from ESENSE2 is consistent with the profile seen in previous clinical studies of nalmefene. In all three clinical studies the overall safety profile of nalmefene was consistent with observations and data provided in previous studies making 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 upon stopping treatment.
Heavy drinking level is defined as five or more drinks per day for men and four or more drinks per day for women. Individuals on 20mg nalmefene had after six months of treatment a decrease of heavy drinking days by more than 50%. Furthermore, data from the 12 month safety study (SENSE) confirmed that this effect is maintained and even improved after one year of treatment; leading to more than 60% overall reduction in total alcohol consumption. Approximately 2/3 of the individuals in the studies have not been treated for alcohol dependence before, indicating that reduction of alcohol intake is an attractive alternative treatment objective compared to current treatments which all require abstinence.
Lundbeck plans to submit a European Marketing Authorisation Application (MAA) for nalmefene as a treatment for alcohol dependence towards the end of 2011. The presentation of the efficacy and safety data at scientific meetings and conferences is planned during the next 12 months.
Nalmefene builds on a novel principle of treating alcohol dependence. Unlike existing therapies, the treatment with nalmefene can be used on an as-needed basis allowing individuals to be in control of their treatment and limit the intake of alcohol rather than requiring full abstinence. Reduction of alcohol consumption to less harmful levels is supported by specialists as a valuable treatment option to keep the individuals in treatment and to increase the willingness among patients to initiate treatment. In addition, nalmefene distinguishes itself by being available as a tablet formulation to be taken only according to need, whereas existing pharmaco-therapies must be taken continuously over a longer period of time and with the aim of maintaining abstinence.