Lundbeck says phase 3 trial shows positive results for Cipralex to treat Obsessive-Compulsive Disorder

By E. Janene Geiss

Philadelphia, Nov. 14 - Lundbeck said Monday that results from its two phase 3 studies of Cipralex for Obsessive-Compulsive Disorder show the drug candidate is well tolerated and effective.

The studies, which include 750 patients, demonstrated that Cipralex is effective in acute treatment and long-term treatment of Obsessive-Compulsive Disorder, and reduced the risk of relapse significantly, according to a company news release.

Lundbeck said it will file for approval of the drug for use in OCD treatment in the beginning of 2006. Cipralex is already approved to treat depression, panic disorder, social anxiety disorder and generalized anxiety disorder.

"We are pleased to have very convincing data demonstrating the effectiveness of Cipralex in the treatment of patients with OCD. Patients suffering from this condition often also have to suffer from considerable stigmatization," Anders Gersel Pedersen, Lundbeck's head of drug development, said in the release.

The dosing study was a double-blind, placebo-controlled study randomized at 10 mg or 20 mg and 40 mg or placebo. The duration of the study was 24 weeks with primary efficacy endpoint reached after 12 weeks, considered acute treatment, officials said.

The long-term efficacy study was further supported by a relapse-prevention study of 320 patients following treatment for 16 weeks randomized to either placebo or Cipralex for an extended 24 weeks of double-blind treatment. The primary endpoint was time to relapse. The study resulted in 81 patients on placebo relapsing and 38 Cipralex patients relapsing. Risk of relapse was 2.7 times higher for the placebo, officials said.

Lundbeck is a Copenhagen, Denmark, pharmaceutical company focused on treatment of psychiatric and neurological disorders.

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