“With the approval for the treatment of OCD, Cipralex is now approved for the treatment of all major anxiety indications and depression,” said senior vice president Anders Gersel Pedersen, head of Development at Lundbeck.
Lundbeck said the approval was granted by the Swedish Medical Products Agency (MPA) acting as reference member state for the European Union.
The approval is based on clinical studies involving more than 750 patients, which demonstrate that Cipralex is an effective and well-tolerated drug in the treatment of obsessive compulsive disorder (OCD) with the added benefit of significantly reducing the risk of relapse in these patients.
The duration of the study was 24 weeks with a primary efficacy assessment after 12 weeks. At week 12, 20mg Cipralex showed a statistically significant greater improvement in the Yale-Brown Obsessive Compulsive Scale compared to placebo.
The primary endpoint was time to relapse. The number of relapses during treatment with Cipralex was 23%, significantly lower compared to the patients in the placebo group which was 52%.
OCD is a chronic, highly debilitating disorder that is characterized by recurrent, distressing thoughts and impulses and/or repetitive behaviors.