Nalmefene Phase 3 completed - Biotie´s partner planning MAA by the end of 2011
Biotie's partner, H. Lundbeck A/S, has announced the completion of ESENSE2, the last study in its Phase 3 program evaluating nalmefene for the treatment of alcohol dependence. Results from this 718 patient, double-blind, placebo controlled trial were consistent with the profile observed in previous clinical studies of nalmefene. Lundbeck plans to file a marketing authorization application (MAA) in Europe by the end of 2011.
Timo Veromaa, President and CEO of Biotie said, "The conclusion of the Phase 3 program is an important milestone for Biotie and we are excited that Lundbeck is on track to submit this extensive clinical data package to the regulators in Europe by the end of this year. Nalmefene is the first treatment that has been specifically developed to help patients reduce their harmful levels of alcohol consumption, therefore offering patients, physicians and payors a highly differentiated treatment option".
Nalmefene builds on a novel principle of treating alcohol dependence. Unlike existing therapies, treatment with nalmefene is not aimed at keeping patients from drinking. Instead, nalmefene helps patients control and limit the intake of alcohol. This is supported by specialists as a valuable treatment option to increase willingness among patients to initiate treatment and to promote compliance. In addition, nalmefene distinguishes itself by being available as a tablet formulation to be taken only according to need, whereas existing pharmaceuticals must be taken continuously over a longer period of time and are aimed at maintaining abstinence.
Lundbeck assessed a wide range of primary and secondary endpoints in its Phase 3 program for nalmefene including: number of heavy drinking days per month, total alcohol consumption, 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. Overall, nalmefene reduced heavy drinking days and total alcohol consumption by more than 50% compared to pre-treatment baseline. The effect was observed already during the first month of treatment and was maintained throughout the study period in the three trials.
Reduction of alcohol instead of abstinence
Furthermore, data from the 12-month safety study (SENSE) confirmed that the treatment effect of nalmefene was maintained and even improved after 1 year of treatment. Approximately two-thirds of the individuals in the studies had previously not been treated for alcohol dependence, despite an ongoing affliction, indicating that reduction of alcohol intake represents an attractive treatment objective compared to current treatments which all require abstinence.
The safety profile of nalmefene was consistent with observations and data provided in earlier studies, including Biotie's previously completed Phase 3 program. The most frequent adverse events in patients taking nalmefene were dizziness, insomnia and nausea. These adverse events were usually mild and transient in nature. The three studies in the Lundbeck Phase 3 clinical program were conducted in Europe and enrolled about 2,000 individuals with alcohol dependence. Including prior studies conducted by Biotie, the total clinical database now contains more than 3,000 patients with alcohol dependence.
Detailed efficacy and safety data is expected to be submitted by Lundbeck for presentation at scientific and medical meetings over the next 12 months.
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