Seroquel SR submitted in Canada and Europe

AstraZeneca has made severel regulatory submissions for the sustained-release formulation of its antipsychotic Seroquel (quetiapine fumarate). The Anglo-Swedish drug major has filed for marketing authorizations for the agent as a treatment for schizohprenia in Europe and Canada.

A few months ago, the London-headquartered firm submitted a New Drug Application to the US Food and Drug Administration for the once-daily formulation (Marketletter July 24). The clinical trials supporting the submission used a short titration period aimed at achieving a therapeutically-effective dose by the second day of the treatment course.

Last year, results from the eight-week, multicenter, randomized, double-blind, placebo-controlled BOLDER study demonstrated that Seroquel, which is the most prescribed atypical antipsychotic, achieving global sales of $2.8 billion in 2005, is approximately twice as effective as a placebo in reducing suicidal ideation in patients with bipolar depression after just one week of treatment. The trial found that the agent significantly bettered core symptoms of depression and anxiety, improving nine out of 10 Montgomery-Asberg Depression Rating Scale (Marketletter July 18, 2005).