H. Lundbeck A/S (Lundbeck) today announced the completion of two out of three pivotal studies in the phase III clinical programme for nalmefene in alcohol dependence (ESENSE1 and SENSE).
The studies were conducted in Europe and enrolled about 1,300 patients with alcohol dependence.
A concomitant psychosocial intervention in the studies was a brief, standardised programme focussed on adherence and follow-up. No abstinence treatment goals were imposed.
In both studies the overall safety profile of nalmefene was consistent with observations and data provided in previous studies.
The most frequent adverse events included dizziness, insomnia and nausea.
“We are pleased that these data demonstrate that nalmefene is on track to become the first drug to make a difference for the many people in need of a reduction of their harmful alcohol consumption” says Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck, and continues: “We will now finalise the last efficacy study in the programme to assess the full data package in order for us to prepare the registration of nalmefene in Europe.”
We expect to complete the third and final phase III study (ESENSE 2) in the second quarter of 2011.
Lundbeck will be initiating a dialogue with the healthcare agencies as well as scientific advisors to discuss the study outcomes and the plans for submitting a European Marketing Authorization Application (MAA) for nalmefene as a treatment for alcohol dependence.
It is Lundbeck’s view that nalmefene is on track for submission of the European MAA in the second half of 2011, but it will as planned depend on the outcome of the final short-term pivotal efficacy study.
The presentation of the efficacy and safety data at scientific meetings and conferences is planned following the completion of all three pivotal studies.
Nalmefene builds on a novel principle of treating alcohol dependence.
Unlike existing therapies, the treatment with nalmefene is not aimed at keeping the patients from drinking.
Instead, nalmefene helps to control and limiting the intake of alcohol.
Reduction of alcohol consumption to less harmful levels is supported by specialists as a valuable treatment option to keep the patients 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 pharmaceuticals must be taken continuously over a longer period of time and for the aim of maintaining abstinence.