Lundbeck files application for approval of Cipralex® for the treatment of Obsessive-Compulsive Disorder (OCD)
28-04-2006, H. Lundbeck A/S has filed an application for approval of Cipralex® (escitalopram) for the treatment of OCD in the EU with the health authorities in Sweden, which acts as reference country in the European mutual recognition procedure.
The application is based on studies involving more than 750 patients, showing that Cipralex® is effective in acute treatment and long-term treatment of OCD as well as reducing the risk of relapse significantly. In Europe, Cipralex® is currently approved for the treatment of depression, panic disorder, social anxiety disorder and generalised anxiety disorder.
About the clinical studies
Dose finding study:
In a double blind placebo controlled study 458 OCD patients were randomised 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 – 20mg escitalopram showed a statistically significant greater improvement in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) compared to placebo (p<0.005). 10mg escitalopram compared to placebo was (p=0.052). At week 24 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) than in the placebo group – as did paroxetine 40mg (p<0.05).
Relapse prevention study
The long-term efficacy was further supported by a relapse prevention study, where 320 patients (intention-to-treat), following treatment with escitalopram for 16 weeks, were randomised to either placebo or escitalopram for a 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 (p<0.001). The number of relapses during treatment with escitalopram (23%) was significantly lower compared to the patients in the placebo group (52%) (p<0.001). The risk of relapsing was 2.7 times higher for the placebo group compared to patients treated with escitalopram.
OCD is a chronic and disabling disorder with lifetime prevalence of 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 that 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 financial result for 2006.
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). The number of employees is approx. 5,000. For further information, visit www.lundbeck.com
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