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Results from two phase III studies of Cipralex® (escitalopram) show that Cipralex® is effective and well tolerated in the treatment of patients suffering from Obsessive-Compulsive Disorder (OCD).
The studies include more than 750 patients and show that Cipralex® is effective in acute treatment and long-term treatment of OCD as well as reducing the risk of relapse significantly.
"We are pleased to have very convincing data demonstrating the effectiveness of Cipralex® in the treatment of patients with OCD. Patients suffering from this condition often also have to suffer from considerable stigmatization", says Anders Gersel Pedersen, head of Lundbeck's drug development.
Cipralex® is currently approved for the treatment of depression, panic disorder, social anxiety disorder, and generalised anxiety disorder. Lundbeck will pursue to file for approval of OCD in the beginning of 2006.
About the clinical studies
Dose finding study:
In a double blind placebo controlled study 458 OCD patients were enrolled, randomized to either escitalopram at one of the two doses (10mg or 20mg), or 40mg paroxetine or placebo. The duration of the study was 24-weeks with a primary efficacy assessment after 12 weeks (acute treatment).
At week 12 - the primary efficacy endpoint - 20 mg escitalopram showed a statistically significant improvement in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) compared to placebo (p<0.005). 10 mg escitalopram compared to placebo was (p=0.052). At week 24 both dosages of escitalopram 10mg (p<0.05) and 20mg (p<0.005) showed a statistically significant greater improvement in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score than in the placebo group - as did paroxetine 40 mg (p<0.005).
Relapse prevention study:
The long-term efficacy was further supported by a relapse prevention study, where 320 patients (intention-to-treat) were following treatment with escitalopram for 16 weeks randomized to either placebo or escitalopram for further 24 weeks of double-blind treatment.
The primary endpoint was time to relapse. The result of this primary analysis showed a significant difference in favour of escitalopram: 81 placebo patients and 38 escitalopram patients relapsed (Log-rank test p<0.001). Thus the risk of relapsing was 2.7 times higher for the placebo compared to escitalopram treated patients.
About OCD
OCD is a chronic and disabling disorder with lifetime prevalence around 2-4%. It is estimated that OCD patients represent more than 10% of patients with anxiety disorders.
Symptoms of OCD can vary, and the obsessions can be thoughts, which are often very disturbing to the patient and can lead to compulsive behaviour. Examples of compulsions are repetitive behaviours (such as excessive hand washing/cleaning/hoarding/checking) and mental acts (such as counting/repeating words).
The content of this release will have no influence on the Lundbeck Group's expectations for the financial result for 2005.
Lundbeck contacts
Steen Juul Jensen
Vice President
+45 36 43 30 06
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 (approx. EUR 1.3 billion). The number of employees is approx. 5,000. For further information, visit www.lundbeck.com
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