Lundbeck says study shows superiority of Cipralex over Paxil/Seroxat in depression

By Ted A. Knutson

Washington, Feb. 27 - Lundbeck said Monday it has presented new clinical data for Cipralex (escitalopram) in major depression at the International Anxiety Disorders Conference in Stellenbosch, South Africa, showing superiority of the drug in comparison with Paxil/Seroxat (paroxetine).

Cipralex is an allosteric serotonin reuptake inhibitor (ASRI) 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.

Lundbeck said 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 generalized anxiety disorder and social anxiety disorder. The data confirm that Cipralex is superior to Paxil/Seroxat within the treatment of depression," said Lundbeck senior vice president Anders Gersel Pedersen in a news release. "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."

The study was a randomized, 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. In the study, 229 patients received treatment with Cipralex 20 mg (10 mg in week one) and 225 patients received treatment with Paxil/Seroxat 40 mg (20 mg in week one).

At endpoint after 24 weeks, the mean change from baseline in the total Montgomery-Asberg Depression Rating Scale (MADRS) score showed significant efficacy in favor of Cipralex (p<0.05). The difference on the MADRS (LOCF) was significantly in favor of Cipralex from week eight 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 a placebo and judged clinically relevant for granting a marketing authorization. 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 favor 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 favor 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 at 8% compared to Paxil/Seroxat at 16% (p<0.05).

Lundbeck is a Copenhagen, Denmark-based biotechnology company focusing on depression, Alzheimer's disease, schizophrenia and sleep disorders.

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