AstraZeneca has submitted a New Drug Application (NDA) to the US Food and Drug Administration for a sustained release (SR) once-daily formulation of Seroquel for the treatment of patients with Schizophrenia.
The clinical trials to support the US submission of seroquel srtm used a short titration period aimed at achieving a therapeutically effective dose by the second day of treatment. The company also expects to make a Seroquel SRTM filing in the European Union towards the end of 2006. The SR formulation has patent protection to 2017.
Seroquel (quetiapine fumarate) has a well-established safety and efficacy profile and to date over 16 million people have been treated worldwide. Seroquel has been licensed for the treatment of schizophrenia since 1997 and it is available in 85 countries for the treatment of this condition. Seroquel is also licensed in 73 countries for the treatment of mania associated with bipolar disorder. Following the recent regulatory submissions based on the bolder studies in bipolar depression, seroquel is set to become the first medication to offer a single treatment effective at both poles of bipolar disease (depression and mania).
Seroquel is the number one prescribed atypical antipsychotic in the US, with global sales of almost $2.8 billion in 2005.