News 2011 › 2011-06-17
Phase 3 trial of Biotie’s nalmefene completed
The final study in the Phase 3 programme evaluating the use of Biotie’s nalmefene for treating alcohol dependence has been completed by the company’s partner, Lundbeck.
The results from the double-blind, placebo-controlled trial, which involved 718 patients, were consistent with the profile observed in previous clinical studies – and Lundbeck plans to file a marketing authorization application (MAA) in Europe later this year. Including prior studies conducted by Biotie and Lundbeck, the total clinical database on nalmefene now contains more than 3,000 patients with alcohol dependence.
“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 providers a highly differentiated treatment option,” says Biotie’s President and CEO, Timo Veromaa.
As a small molecule opioid receptor antagonist, nalmefene does this by inhibiting the reward pathway in the brain that reinforces the desire and craving for alcohol and other addictive substances. It also only needs to be taken when needed, whereas existing pharmaceuticals must be taken continuously over a longer period and are aimed at maintaining abstinence.
The Lundbeck-coordinated programme confirmed that nalmefene reduced heavy drinking days and total alcohol consumption by more than 50% compared to the pre-treatment baseline, and was effective from the first month of treatment onwards. Data from a 12-month safety study also confirmed that the treatment effect was maintained and even improved after a year of treatment.