Release number: 46
Release date: 09-05-2001
Release time: 13:00
The results of several clinical studies including two pooled analyses of three, phase III placebo-controlled studies were published today at the American Psychiatric Association meeting in New Orleans. The studies incorporate results from 1,335 patients with major depressive disorder treated with CipralexÔ, citalopram or placebo.

The studies show that:

• Cipralex^TM, a more potent and selective serotonin reuptake inhibitor (SSRI) than citalopram, demonstrates consistent statistical superiority to placebo treatment at a dose of only 10 mg/day and is very well tolerated.
• Cipralex^TM is shown at a dose of 10 mg/day to produce larger mean changes on key efficacy endpoints relative to placebo than did citalopram (20 or 40 mg/day)
• Cipralex^TM demonstrates statistically significant superior effects compared to placebo already at week one or two on all efficacy parameters. This is an earlier separation from placebo than was demonstrated for citalopram. 
• Cipralex^TM also significantly improves anxiety symptoms in depressed patients.
• Cipralex^TM demonstrates statistical separation from placebo as early as week one while citalopram demonstrated significant separation at week four.

 

Cipralex^TM consistently improved depressive symptoms and produced greater effects relative to placebo than did citalopram on the MADRS at all time points. This combined with its high tolerability makes Cipralex^TM well suited as first line treatment for all types of depression.
 
�I am very pleased with these results. Cipralex^TM is more than just a refinement of citalopram. The clinical studies revealed the remarkably robust and early effect of Cipralex^TM. The discontinuation rate on 10 mg/day was very low and comparable to that of placebo. Furthermore, Cipralex^TM is also very well tolerated and shows promise as a valuable contribution to improving the treatment of depression,� says Erik Sprunk-Jansen, President & CEO of Lundbeck.

�With a consistently early onset and the activity, as seen on parameters such as anxiety and inner tension, Cipralex^TM shows great promise for the treatment of both anxiety and mood disorders, says Dr. Claus Bræstrup, Executive Vice President for Research & Development at Lundbeck.

The content of this release does not alter Lundbecks expectations for the financial year 2001.

For further information please contact Senior Vice President & CFO, Hans Henrik Munch-Jensen, phone +45 36 30 15 11, ext. 2660.

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H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of drugs for the treatment of psychiatric and neurological diseases. It had consolidated net turnover of DKK 5.6 billion in 2000 and employs approximately 3,000 people.

 

H. Lundbeck A/S
Ottiliavej 9
DK-2500 Copenhagen Valby

Phone +45 3630 1311
Fax +45 3630 1940

information@lundbeck.com