Biotie Announces Positive Results from First Two Phase III Studies with Nalmefene in Alcohol Dependence
Biotie's partner, H. Lundbeck A/S, has announced that it has completed two Phase III clinical trials evaluating nalmefene for the treatment of alcohol dependence (ESENSE1, SENSE). Lundbeck expects to complete a further efficacy study (ESENSE2) in 2Q 2011 and plans to file a marketing authorisation application (MAA) in Europe in 2H 2011, depending on the outcome of the final study. Lundbeck plans to submit detailed efficacy and safety data for presentation at scientific and medical meetings after all three trials have been completed.
Timo Veromaa, Chief Executive Officer of Biotie stated: "We are delighted with the continued favourable profile of nalmefene and look forward to the results from ESENSE2 later this year. We believe that nalmefene could significantly transform the treatment of alcohol dependence by providing patients with a real alternative to current abstinence-based therapies. Helping patients to reduce harmful levels of alcohol consumption is an important clinical goal and we believe the unique "as needed" approach with nalmefene - which aims to put the patient back in control of their disease - could create a real paradigm shift in the management of alcohol dependence. We are excited to be working with our partner Lundbeck, a global leader in CNS drug development, to bring this important product to market."
ESENSE1, a 24-week efficacy study, and SENSE, a 52-week safety study, were designed to investigate efficacy and safety of 20mg nalmefene taken "as needed" versus placebo in patients with alcohol dependence. In both studies, which enrolled around 1,300 patients in total, psychosocial intervention consisted of a brief, standardised programme focussed on adherence and follow-up. No abstinence treatment goals were imposed. The data from these studies is consistent with the profile of nalmefene observed in previous clinical studies. The most frequent adverse events included dizziness, insomnia and nausea.
Lundbeck has indicated it will initiate a dialogue with the healthcare agencies, as well as scientific advisors, to discuss the outcomes from these clinical trials and its plans for submitting a European Marketing Authorization Application (MAA) for nalmefene as a treatment for alcohol dependence. "We expect Lundbeck to assess the full data package, including results from the final Phase III trial (ESENSE2), before filing nalmefene in Europe", commented Dr. Veromaa.
Biotie has previously conducted three Phase II studies and two Phase III studies in alcohol dependence. The largest of the previous Phase III trials, conducted in 400 patients with alcohol dependence, demonstrated that nalmefene, taken "as needed", significantly reduced the average alcohol intake per patient and the number of heavy drinking days (classed as intake above five standard drinks of alcohol). Previous trials have also shown nalmefene to be well-tolerated and safe. Biotie's patient dossier for nalmefene includes approximately 1,100 patients and will expand to approximately 3,000 patients when all three Phase III studies being conducted by Lundbeck have been completed.
Nalmefene builds on a novel principle of treating alcohol dependence. Unlike existing therapies, treatment with nalmefene is not aimed at keeping the patients from drinking. Instead, nalmefene helps to control and limit the intake of alcohol. Reduction of alcohol consumption to less harmful levels is supported by specialists as a valuable treatment option to increase willingness among patients to initiate treatment and to keep the patients in treatment. In addition, nalmefene distinguishes itself by being available as a tablet formulation to be taken only according to need, ("as needed"), whereas existing pharmaceuticals must be taken continuously over a longer period of time and are aimed at maintaining abstinence.
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