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December 10, 2004


Topics: Clinical Pharmacology

FDA News, Drug Daily Bulletin.

Danish pharmaceutical group Lundbeck said on Friday it had won approval in Canada to launch its Alzheimer's drug Ebixa before the end of the year. "Ebixa has a unique mechanism of action and is the first and only drug approved for the treatment of moderate to severe Alzheimer's," Lundbeck said in a statement. At 0912 GMT Lundbeck was trading 2.5 percent up at 112 crowns, while the Copenhagen blue-chip KFX index was up 0.2 percent.

Related Information: Recently completed clinical studies demonstrate positive effects of memantine(Ebixa) in Alzheimer's disease both as a monotherapy and in patients receiving continuous donepezil treatment.

Memantine(Ebixa) treatment also has demonstrated significant improvement of cognitive performance in patients suffering from vascular dementia.

Furthermore, the safety and tolerability of memantine(Ebixa) in clinical trials has been excellent, with the incidence of premature withdrawals due to adverse events no greater than placebo and overall low frequencies of total adverse events. In 2002, memantine was approved by the European Medicines Agency (EMEA) for the treatment of moderately severe to severe Alzheimer's disease. More recently, memantine was approved in the US for the treatment of moderate to severe Alzheimer's disease (October 2003).  Drugs Today (Barc). 2004 Aug;40(8):685-95  PMID: 15510240

Posted by Hyscience at December 10, 2004 11:44 PM

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