Lexapro®/Cipralex® demonstrated significance on
prospectively defined efficacy parameter and was better tolerated
than Cymbalta® in treatment of depression
<span class="TeaserText">Release number: 252<br /></span>
<span class="TeaserText">Release date: 06-12-2006</span>
<span class="TeaserText">Release time: 14:00</span><br />
H. Lundbeck A/S´s partner in the US Forest Laboratories- Inc. today announced the results of a new head to head study of Lexapro®/Cipralex® (escitalopram oxalate) versus Cymbalta® (duloxetine). The study demonstrated Lexapro®/Cipralex® to provide a greater reduction in MADRS scores- p=0.040- utilizing an LOCF approach and was better tolerated than Cymbalta® (duloxetine)- based on the percentage of patients discontinuing treatment due to adverse events- in the treatment of patients with moderate to severe major depressive disorder (MDD).
Dr. Arif Kahn- Medical Director of Northwest Clinical Research Center and investigator in this study said- “These findings add to a number of studies that demonstrate the clinical value of Lexapro® in the treatment of depression.”
<strong>Study details<br /></strong>Patients (aged 18-80 years) with DSM-IV diagnosed MDD as determined by a Montgomery-Asberg Depression Rating Scale (MADRS) score of 26 or greater were randomized to eight weeks of double-blind treatment with Lexapro®/Cipralex® 10-20 mg/day (dose fixed at 10 mg/day for the first four weeks with optional up-titration to 20 mg/day thereafter) or Cymbalta® 60 mg/day. Dosing of the two antidepressants was consistent with information in the FDA-approved package insert of both drugs. The primary- prospectively-defined- efficacy endpoint was the change from baseline at week eight in the MADRS total score- using the last observation carried forward (LOCF) approach. At the start of the study- 137 patients were enrolled in the Lexapro®/Cipralex® arm of the study and 133 in the Cymbalta® arm.
At the end of the eight-week study- Lexapro®/Cipralex® patients demonstrated significantly greater improvement than Cymbalta® patients in the total MADRS score (LSMD- least squared mean difference- -2.42 [95% CI: -4.73- -0.11]; p=0.040) - predefined primary endpoint. The proportion of patients responding to Lexapro®/Cipralex® treatment- as determined by a 50 percent improvement in MADRS total score- also was significantly greater when compared to patients in the Cymbalta® group (68 percent vs. 52 percent- p=0.011; LOCF). Remission rates were 44 percent in the Lexapro®/Cipralex® group and 38 percent in the Cymbalta® group- as determined by a total MADRS score of 10 or less- this difference was not significant. The rate of improvement on the MADRS was similar between the groups when an observed case analysis was conducted. In addition- there was no difference seen between the group on a number of measures of relief of somatic and pain-related symptoms.
More patients in the Lexapro®/Cipralex® group completed eight weeks of treatment than patients in the Cymbalta® group (87 percent vs. 69 percent- p=0.001) and significantly fewer patients receiving Lexapro®/Cipralex® discontinued treatment due to adverse events compared to patients receiving Cymbalta® (2 percent vs. 13 percent- p=0.001).
Forest Laboratories licenses Lexapro® from H. Lundbeck A/S.
The content of this release will have no influence on the Lundbeck Group’s financial result for 2006.
Steen Juul Jensen
+45 36 43 30 06
Mads Bjerregaard Pedersen
Investor Relations Officer
Media Relations Manager
+45 36 43 41 04
+45 36 43 26 38
Investor Relations Manager-
+1 201 350 0187
<br /><br />
<strong>Stock exchange release No 252 - 6 December 2006</strong>
<strong>About Lundbeck</strong><br /> 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 2005- the company’s revenue was DKK 9.1 billion (approximately EUR 1.2 billion or USD 1.5 billion). The number of employees is approximately 5-000 globally. For further information- please visit <a href="http://www.lundbeck.com/">www.lundbeck.com</a>