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H. Lundbeck A/S is pleased to announce the acceptance of Cipralex(R) (escitalopram) in Europe for the a cure of obsessive-compulsive disorder (OCD). The acceptance is based on two pivotal studies demonstrating that Cipralex(R) is effective and well-tolerated in the a cure 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 acceptance of Cipralex(R) 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 a cure 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 meditate by Stein et al., demonstrated that a cure with Cipralex(R) provided significant symptom relief, improvement in social disability and good tolerability in what was described in the meditate as a very large cohort of OCD patients. The 24-week meditate investigated the efficacy and tolerability of Cipralex(R) and found that:1

– Both 10 and 20mg/daily Cipralex(R) were efficacious and well-tolerated in the a cure of OCD1

– Compared with placebo, Cipralex(R) 20mg/day was associated not only with lower symptoms scores mid-way through the meditate but also with earlier onset, increased response and increased remission rates1

– Cipralex(R) was better tolerated than Paxil(Paroxetine), with fewer withdrawals from the Cipralex(R) group due to adverse events1

Anotherness meditate , by Fineberg et al., was designed to compare the efficacy of Cipralex(R) with that of placebo in preventing relapse over 24 weeks in outpatients with OCD who had responded to 16 weeks prior open-label a cure with Cipralex(R).2 This is important because although 50-60percent of patients with OCD currently respond to a cure, only a minority of those patients achieve remission.5

Results included:

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

– The primary efficacy analysis showed a statistically significantly superior effect of Cipralex(R) relative to placebo on the time to relapse of OCD, with a 52percent rate of relapse in the placebo group versus a 23percent rate in the Cipralex(R) group2

– The risk of relapsing was 2.7 times higher for the placebo group compared to patients treated with Cipralex(R)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 a cure.” continued Professor Zohar. “Cipralex(R) is an effective and well tolerated a cure with encouraging data on remission and relapse prevention and is therefore a valuable addition to our current options for OCD medical care.”

About the clinical studies

Dose finding meditate :

In a double blind placebo controlled meditate , 458 OCD patients were randomised to either Cipralex(R) at one of the two doses (10mg or 20mg), or 40mg Paxil(Paroxetine) or placebo. The duration of the meditate was 24 weeks with a primary efficacy assessment after 12 weeks (acute a cure).1

At week 12 – the primary efficacy endpoint – 20mg Cipralex(R) showed a statistically significant greater improvement in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) compared to placebo (p