FDAnews
www.fdanews.com/articles/89433-lundbeck-s-cipralex-approved-in-europe-for-ocd

LUNDBECK'S CIPRALEX APPROVED IN EUROPE FOR OCD

January 19, 2007

Lundbeck has announced 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.

One pivotal study demonstrated that treatment with Cipralex provided significant symptom relief, improvement in social disability and good tolerability in a large cohort of OCD patients. The 24-week study investigated the efficacy and tolerability and found that Cipralex was better tolerated than paroxetine, with fewer withdrawals from the Cipralex(R) group due to adverse events.

Another study 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. 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 percent rate of relapse in the placebo group versus a 23 percent rate in the Cipralex group.