With high hopes to change the way alcohol dependence is treated, Copenhagen-based drug company Lundbeck has shown that its experimental pill nalmefene has passed a final Phase III trial in route to potential European approval.
The late-stage trials of drug, which a Lundbeck ($LUN.CO) executive has tagged as a potential blockbuster, have provided a nice package of data on safety, efficacy and tolerability of the treatment. In a key measure of efficacy in the latest Phase III, patients on the drug showed a more than 50 percent drop in the number of heavy drinking days--which was five drinks for men and four for women--after six months of treatment. And the company again says that it's on track to submit its application to European regulators for approval of the drug by late 2011.
"Across the clinical phase III program consistency and robustness were observed and the studies support the overall positive clinical profile of nalmefene," Anders Gersel Pedersen, head of drug development at Lundbeck, said.
Rather than quitting cold turkey, patients take Lundbeck's drug on an as-needed basis to reduce their intake to levels that they control, according to the company. While Lundbeck chief executive Ulf Wiinberg has said that nalmefene could become a $1 billion-plus annual seller, Reuters reports, the news service cites analysts who peg upside annual sales of the drug at $250 million to around $500 million.
A potential 2013 launch of the drug in Europe could ease the expected pain that Lundbeck faces with increased generic drug competition in the coming years to what Reuters reports is the firm's top moneymaker, the antidepressant Lexapro.
- here's the Lundbeck release
- read the Reuters report