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Title: Data Presented Indicates Escitalopram may be a Promising Future Treatment Option in Obsessive Compulsive Disorder

"Data Presented Indicates Escitalopram may be a Promising Future Treatment Option in Obsessive Compulsive Disorder"

PARIS, FRANCE -- September 19, 2006 -- New data presented today demonstrates that escitalopram is efficacious and well tolerated in the treatment of Obsessive Compulsive Disorder (OCD) with encouraging rates of remission and relapse prevention.(1,2) Presented at a satellite symposium on the occasion of the 19th ECNP Congress in Paris, France, supported by an unrestricted educational grant from Lundbeck, the data suggests that escitalopram may be a promising future treatment option for this common and debilitating condition. OCD is a chronic, highly debilitating disorder that is characterised by recurrent, distressing thoughts and impulses (obsessions) and/or repetitive behaviours (compulsions).(3) It is the 10th leading cause of disability of all medical conditions in the industrialised world and affects all aspects of quality of life.(4) Although 50-60% of patients currently respond to treatment, only a minority achieve remission.(5) "Effective treatment for OCD is vital and achieving remission should be the minimum goal of therapy to avoid relapse and achieve full patient recovery", said Prof Naomi A Fineberg, Consultant Psychiatrist and Honorary Senior Lecturer, Imperial College London and University of Hertfordshire. "These new data suggest that escitalopram is effective for acute and long-term treatment and relapse prevention in OCD and deserves to be considered as one of the first-line agents for OCD treatment." Obsessive spectrum disorders over the life cycle - Lundbeck-supported satellite symposium Lead investigators Prof Dan J Stein and Prof Fineberg presented findings from the first randomised controlled trial of escitalopram in the treatment of OCD.(1) The 24-week study investigated the efficacy and tolerability of escitalopram and found that: - Both 10 and 20mg/daily escitalopram were efficacious and well-tolerated in the treatment of OCD(1) - Compared with placebo, escitalopram 20mg/day was associated not only with lower symptoms scores mid-way through the study but also with earlier onset, increased response and increased remission rates(1) Data from a separate randomised, double-blind, placebo-controlled relapse prevention study conducted by Stein and Fineberg was also presented and the results further demonstrated the ability of escitalopram to prevent relapse.(2) The study was designed to compare the efficacy of escitalopram with that of placebo in preventing relapse over 24 weeks in outpatients with OCD who had responded to 16 weeks prior open-label treatment with escitalopram.(2) Results included: - Escitalopram 10 or 20 mg/day was well tolerated and significantly reduced the risk of relapse in patients with OCD, had an anti-OCD effect during 16 weeks of open-label treatment and a significant relapse-preventing effect during continued treatment up to 24 weeks(2) - The primary efficacy analysis showed a statistically significantly superior effect of escitalopram relative to placebo on the time to relapse of OCD, with a 52% rate of relapse in the placebo group versus a 23% rate in the escitalopram group(2) Driving Forward the Optimal Management of OCD OCD was the focus of a recent consensus group review at the International Anxiety Disorders Conference (IADC) in Cape Town, South Africa in February 2006. The group, which included Stein and Fineberg reviewed the currently available scientific data on the symptomatology, diagnosis, assessment, psychobiology and treatment of OCD in order to provide an up-to-date summary of the literature and enable them to make recommendations for treating physicians.(6) "Due to the chronic nature of OCD and its severe impact on quality of life, it is essential that those living with the disorder receive long-term care and effective treatment," said Prof Stein, Chair, Department of Psychiatry, University of Cape Town and Director of the Medical Research Council Unit on Anxiety Disorders, University of Stellenbosch, South Africa. "This is why we felt it vital to convene a group of experts to assess the current management of OCD and to develop recommendations to improve the ongoing management of this disabling condition." The consensus also looked at the current controversy surrounding the classification of OCD and whether it should be classified as an anxiety disorder or if classification within the group of Obsessive Compulsive Spectrum Disorders (which includes body dysmorphic disorder, pathological gambling, certain eating disorders and autism) would be more appropriate.(6,7) The content of this release will have no influence on the Lundbeck Group's financial result for 2006. About OCD OCD affects between 2-3% of the general population(6) and is associated with significant functional disability and economic costs.(1) OCD has a number of manifestations but involves having both obsessions and compulsions. A common obsession is around dirt, germs and contamination. As compulsions are acts performed repeatedly in hopes of obtaining relief from obsessions, those with OCD may wash compulsively to the point that their hands become raw and inflamed. - Up to 2/3 of individuals with OCD suffer from co-morbid depression at some time during their illness(8) - Symptomatology often starts as early as childhood or adolescence and affects a majority of the patients for their whole life, requiring long-time care and treatment(9) - OCD affects men and women equally(3) - OCD often goes unrecognised. On average, people with OCD see three to four doctors and spend 9 years seeking treatment before they receive a correct diagnosis. Studies find that it takes an average of 17 years from the time OCD begins for people to obtain appropriate treatment(10) REFERENCES: 1. Stein DJ, Tonnoir B, Andersen EW, Fineberg NA. Escitalopram in the treatment of obsessive-compulsive disorder. 159th Annual Meeting American Psychiatric Association, May 2006, Toronto. 2. Fineberg NA, Lemming O, Stein DJ, Tonnoir B. Escitalopram in relapse prevention in patients with obsessive-compulsive disorder. 159th Annual Meeting American Psychiatric Association, May 2006, Toronto. 3. Obsessive Compulsive Disorder. National Institute of Mental Health (NIMH). Last accessed on 23.08.06 from http://www.nimh.nih.gov/Publicat/ocdfacts.cfm. 4. Eisen JL, Mancebo MA, Pinto A, Coles ME, Pagano ME, Stout R, et al. Impact of obsessive-compulsive disorder on quality of life. Comprehensive Psychiatry 2006; 47 (4); 270-5. 5. Ballenger JC. Remission rates in patients with anxiety disorders treated with paroxetine. J Clin Psychiatry. 2004 Dec; 65(12):1696-707. 6. Stein DJ et al, "The Cape Town Consensus Statement," International Anxiety Disorders Conference, Cape Town, South Africa, February 2006. 7. Bartz JA, Hollander E. Is obsessive compulsive disorder an anxiety disorder? Prog Neuropsychopharmacol Biol Psychiatry 2006 May; 30(3): 338-52. 8. Fineberg NA, Johansen T, Chamberlain SR. Depression within OCD: from neurobiology and clinical responses toward endophenotypes. University of Hertfordshire, Hatfield, UK. 9. Hollander E. Anxiety and OC spectrum disorders. Mount Sinai School of Medicine, New York USA. 10. About OCD. Obsessive Compulsive Foundation. Last accessed on 23.08.06 from http://www.ocfoundation.org/what-is-ocd.html. SOURCE: H Lundbeck A/S

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