European filing for Nalmefene is projected for second half of 2011, pending data from a third study.
Lundbeck and Biotie Therapies reported positive data from the first two of three Phase III trials evaluating the alcohol dependence therapy candidate nalmefene. A third Phase III efficacy study is due to report during the second quarter of 2011, and submission of a marketing authorization application in Europe is projected for the second half of the year, the firms note.
Lundbeck is developing the small molecule opioid receptor antagonist worldwide under license from Biotie. The two reported European trials, Esense1 and Sense, included about 1,300 alcohol-dependent patients. Esense1 was designed as a placebo-controlled 24-week efficacy study, while Sense was a 52-week safety study. The final Phase III study, Esense2, is an additional six-month efficacy trial.
Nalmefene is an oral drug that, in contrast to existing therapies, is not designed to stop patients from taking any alcohol, Lundbeck and Biotie point out. Instead, nalmefene reduces the desire to drink, and is used by patients on an as-needed basis to help them control their level of alcohol consumption. “We are delighted with the continued favourable profile of nalmefene and look forward to the results of Esesne2 later this year”, comments Timo Veromaa, Biotie CEO. “We believe that nalmefene could significantly transform the treatment of alcohol dependence by providing patients with a real alternative to current abstinence-based therapies. We expect Lundbeck to assess the full data package, including results from the final Phase III trial, Esense2, before filing nalmefene in Europe.”
The reported Phase III development program for nalmefene has been carried out by licensee Lundbeck, but Biotie itself had previously completed three Phase II studies and two Phase III studies. The largest of these Phase III trials, in 400 patients, showed nalmefene significantly reduced the average alcohol intake per patient and the number of heavy drinking days.