Danish drugmaker Lundbeck is expecting to file its alcoholism drug nalmefene in Europe by the end of the year following positive results from the final trial in the drug's Phase III clinical programme.
Results of the multicentre, double-blind, placebo-controlled ESENSE2 trial involving 718 patients were consistent with others from the clinical programme showing that nalmefene was able to induce a significant reduction in alcohol consumption in patients with alcohol dependency.
The clinical trial programme for the drug was designed to assess a number of primary and secondary endpoints, and though some did not reach statistical significance, it was "consistently observed" that nalmefene was able to cut alcohol consumption by over 50% in heavy drinkers, and that this was maintained throughout the study periods.
And importantly, safety data from all three Phase III clinical trials was in line with observations from previous studies, with the most frequently reported side effects being dizziness, insomnia and nausea, all of which were considered mild and transient in nature.
"Across the clinical Phase III programme consistency and robustness were observed and the studies support the overall positive clinical profile of nalmefene", commented executive vice President Anders Gersel Pedersen, head of drug development at Lundbeck, which has helped improve the likelihood of its approval.
If the green light is given, the drug could offer alcoholics a different mode of controlling their illness, as it can be used on an as-needed basis to help reduce alcohol intake rather than requiring full abstinence like traditional treatments.
On the back of the positive trial data Lundbeck said it plans to submit a European Marketing Authorisation Application for nalmefene towards the end of 2011, and present full safety and efficacy data at scientific get-togethers in the next year.
Investors should be pleased by the news given that Lundbeck will likely take a punch to sales when the patents protecting its top-selling drug Cipralex/Lexapro (escitalopram) begin to crumble from next year, and any new drug approvals will help to claw back some of the lost revenues when generics begin to flood the market.