Cipralex® - new data supports the superiority of Cipralex® compared to Paxil®/Seroxat®

27-02-2006, Lundbeck presented new clinical data for Cipralex® (escitalopram) in major depression at the International Anxiety Disorders Conference (IADC) in Stellenbosch, South Africa, showing superiority of Cipralex® in comparison with Paxil®/Seroxat® (paroxetine).


Cipralex® is an ASRI (Allosteric Serotonin Reuptake Inhibitor) antidepressant, which has consistently shown significant efficacy, fast onset of action and excellent tolerability in the treatment of depression and anxiety disorders in multiple clinical trials. Superior efficacy of Cipralex® in comparison with other existing antidepressants has been established in other clinical trials and several meta-analyses. Recently this superiority was shown in a head-to-head comparison with citalopram, confirming findings of previous meta-analyses.

“Previous clinical trials have shown superiority of Cipralex® in comparison to Paxil®/Seroxat® in generalised anxiety disorder and social anxiety disorder. The data confirms that Cipralex® is superior to Paxil®/Seroxat® within the treatment of depression,” says Senior Vice President Anders Gersel Pedersen, Head of Development at Lundbeck. “The data presented once again confirms that the Cipralex® is a better treatment choice than the available SSRIs and SNRIs in the management of patients suffering from either depression or anxiety disorders.”

Study design and results
The study was a randomised, double blind, fixed-dose study evaluating the efficacy of Cipralex® and Paxil®/Seroxat® in the long-term treatment of patients with more severe depressive disorder. 229 patients received treatment with Cipralex® 20mg (10mg in week 1) and 225 patients received treatment with Paxil®/Seroxat® 40mg (20mg in week 1).

At endpoint after 24 weeks, the mean change from baseline in the total Montgomery-Åsberg Depression Rating Scale (MADRS) score showed significant efficacy in favour of Cipralex® (p<0.05). The difference on the MADRS (LOCF) was significantly in favour of Cipralex® from week 8 and onwards. The difference in absolute numbers amounted to 2.1 on the MADRS scale, which is of the same magnitude as observed in a recent direct comparison to citalopram. This difference is similar to the differences observed between antidepressants and placebo and judged clinically relevant for granting a marketing authorisation. The proportion of patients in remission (MADRS ?12) was 75% for Cipralex® and 67% for Paxil®/Seroxat® (p<0.05).

The results on the primary efficacy scale were confirmed by significantly greater difference in favour of Cipralex® on the HAMA, HAMD, CGI-S, and CGI-I scales. For the most severely depressed patients (baseline MADRS 35), there was a difference of 3.5 points in favour of Cipralex® (p<0.01). The overall withdrawal rate for patients treated with Cipralex® was 19% and was significantly lower than with Paxil®/Seroxat®, which was 32% (p<0.01). The withdrawal rate due to adverse events was significantly lower for Cipralex® (8%) compared to Paxil®/Seroxat® (16%) (p<0.05).

Allosteric effect
Serotonin acts as a signalling compound by transmitting nerve impulses from one nerve to another. Too little serotonin can trigger depression and/or anxiety. The level of serotonin is regulated by so-called transporters (serotonin reuptake transporters) at the nerve end. In depression and anxiety where serotonin levels are too low, modern antidepressants increase the level by blocking these transporters.

Research has identified a novel binding site at the serotonin reuptake transporters, a so-called allosteric binding site. It has been established that binding to the primary binding site of the transporter as well as to the allosteric binding site by Cipralex® results in an enhanced interaction at the prime drug target, and may explain superior effects.

The content of this release will have no influence on the Lundbeck Group’s financial result for 2005 or expectations for 2006, which were disclosed in stock exchange release number 198 of 7 February 2006. The Lundbeck Group’s financial result for 2005 will be presented 15 March 2006.

About Lundbeck
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 disorders. In 2004, the company’s revenue was DKK 9.7 billion (approximately EUR 1.3 billion). The number of employees is approx. 5000. For further information, visit www.lundbeck.com

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Caroline Broge

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Lundbeck

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