Healthcare Industry News:  escitalopram 

Biopharmaceuticals Regulatory

 News Release - January 18, 2007

Cipralex Approved in Europe for the Treatment of Obsessive Compulsive Disorder

An Exciting New Treatment Option for Patients With This Chronic, Disabling Disorder

COPENHAGEN, Denmark, January 18 (HSMN NewsFeed) -- H. Lundbeck A/S is pleased to announce the approval of Cipralex® (escitalopram) in Europe for the treatment of obsessive-compulsive disorder (OCD). The approval is based on two pivotal studies demonstrating that Cipralex® is effective and well-tolerated in the treatment of OCD with the added benefit of encouraging rates of remission and relapse prevention in OCD patients.1,2

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

"The approval of Cipralex® in OCD is exciting news for patients living with this disabling condition," said Professor Joseph Zohar, Division of Psychiatry, Sheba Medical Center, Tel Aviv, Israel and President of the International College of Obsessive Compulsive Spectrum Disorders (ICOCS). "Society often underestimates the impact of OCD on daily life and it is vital for patients to have access to a treatment that is both well-tolerated and effective in reducing the symptoms and associated social disability that patients with OCD encounter on a daily basis."

One pivotal study by Stein et al., demonstrated that treatment with Cipralex® provided significant symptom relief, improvement in social disability and good tolerability in what was described in the study as a very large cohort of OCD patients. The 24-week study investigated the efficacy and tolerability of Cipralex® and found that:1

- Both 10 and 20mg/daily Cipralex® were efficacious and well-tolerated in the treatment of OCD1

- Compared with placebo, Cipralex® 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 rates1

- Cipralex® was better tolerated than paroxetine, with fewer withdrawals from the Cipralex® group due to adverse events1

Another study, by Fineberg et al., was designed to compare the efficacy of Cipralex® 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 Cipralex®.2 This is important because although 50-60% of patients with OCD currently respond to treatment, only a minority of those patients achieve remission.5

Results included:

- Cipralex® 10 or 20 mg/day was well tolerated by patients with OCD, had an effect on OCD-symptoms during 16 weeks of open-label treatment and significantly reduced the risk of relapse in patients with OCD during continued treatment of up to 24 weeks2

- The primary efficacy analysis showed a statistically significantly superior effect of Cipralex® 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 Cipralex® group2

- The risk of relapsing was 2.7 times higher for the placebo group compared to patients treated with Cipralex®2

"Given the chronic nature of OCD and associated serious disability, we need to focus not only on the acute phase, but also on how to prevent relapse. As the patient needs to take the medication for extended periods of time, the tolerability of the compound is a key factor in increasing patient adherence to treatment." continued Professor Zohar. "Cipralex® is an effective and well tolerated treatment with encouraging data on remission and relapse prevention and is therefore a valuable addition to our current options for OCD therapy."

Notes to Editors

About the clinical studies

Dose finding study:

In a double blind placebo controlled study, 458 OCD patients were randomised to either Cipralex® 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).1

At week 12 - the primary efficacy endpoint - 20mg Cipralex® showed a statistically significant greater improvement in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) compared to placebo (p<0.005). 10mg Cipralex® compared to placebo was (p=0.052). At week 24 dosages of Cipralex® 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).1

Relapse prevention study

The long-term efficacy was further supported by a relapse prevention study, where 320 patients (intention-to-treat), following treatment with Cipralex® for 16 weeks, were randomised to either placebo or Cipralex® for a further 24 weeks of double-blind treatment.2

The primary endpoint was time to relapse. The result of this primary analysis showed a significant difference in favour of Cipralex® (p<0.001). The number of relapses during treatment with Cipralex® (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 Cipralex®.2

About OCD

OCD affects between 2-3% of the general population 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 illness6

- 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 treatment7

- OCD affects men and women equally3

- 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 treatment8

About the ICOCS

The International College of Obsessive Compulsive Spectrum Disorders (ICOCS) is primarily aimed at advancing, promoting and facilitating research into the causes and consequences of obsessive compulsive disorder and obsessive compulsive spectrum disorders. The organisation intends to aid and stimulate mental health professionals and others to develop research projects in this field, and to help coordinate research efforts amongst members.

The ICOCS also intends to increase public health awareness in regard to OCD and OC spectrum disorders with the hope of improving diagnosis and encouraging better deployment of resources for assessment and treatment.

For more information on the ICOCS, please visit www.icocs.org

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 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

References

1) Stein DJ, Tonnoir B, Andersen EW, Fineberg NA. escitalopram in the treatment of obsessive-compulsive disorder. Data presented at 19th ECNP Congress, September 2006, Paris, France.

2) Fineberg NA, Lemming O, Stein DJ, Tonnoir B. escitalopram in relapse prevention in patients with obsessive-compulsive disorder. Data presented at 19th ECNP Congress, September 2006, Paris, France.

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) Fineberg NA, Johansen T, Chamberlain SR. Depression within OCD: from neurobiology and clinical responses toward endophenotypes. University of Hertfordshire, Hatfield, UK.

7) Hollander E. Anxiety and OC spectrum disorders. Mount Sinai School of Medicine, New York USA.

8) About OCD. Obsessive Compulsive Foundation. Last accessed on 23.08.06 from http://www.ocfoundation.org/what-is-ocd.html


Source: H. Lundbeck

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



FindReps - Find Great Medical Independent Sales Reps without recruiter fees.
FindReps - available on the Apple App Store for iPhone and iPad.