AstraZeneca submits sustained-release Seroquel to EU regulator

AstraZeneca, the UK’s second-largest pharmaceutical company, has submitted Seroquel SR – the sustained release formulation of Seroquel – to European regulators.

The company is seeking marketing authorisation for the drug under the mutual recognition procedure, with the aim of providing patients with schizophrenia with a new, once-daily formulation.

The submission follows a new drug application to the FDA in the US and includes trials involving a titration period, allowing patients to receive a “therapeutically effective” dosage by the second day of treatment.

In January, AstraZeneca submitted a supplemental new drug application to the FDA for Seroquel to treat bipolar depression. Wayne Macfadden, Seroquel’s US medical director, said the application was an “important milestone” as it could make Seroquel the first drug be indicated for “both the depressive and manic episodes”.

Seroquel is the most prescribed atypical antipsychotic drug in the US and was the subject of a 29 per cent increase in sales during the first half of 2006.