AstraZeneca Submits NDA for Seroquel for Schizophrenia

(August 15, 2006) -- AstraZeneca (AZN) has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for a sustained release formulation of Seroquel (quetiapine fumarate) - Seroquel SR in the treatment of patients with schizophrenia.

Seroquel tablets, in the currently available immediate release formulation, are approved for the treatment of acute manic episodes associated with bipolar I disorder and the treatment of schizophrenia.

In clinical trials supporting the FDA submission, the investigational once-daily formulation demonstrated an effective dose range of Seroquel SR of 400-800 mg/day. In addition, these trials aimed to show that an effective dose can be achieved as early as day 2.

The company expects to make a Seroquel SR filing in the European Union towards the end of 2006.

Seroquel is the #1 prescribed atypical antipsychotic in the United States. With a well-established safety and efficacy profile, Seroquel has had more than 16 million patient exposures worldwide since its launch in 1997. In 2005, global sales for Seroquel reached $2.8 billion.

Seroquel is indicated for the treatment of acute manic episodes associated with bipolar I disorder, as either monotherapy or adjunct therapy with lithium or divalproex, and the treatment of schizophrenia. Patients should be periodically reassessed to determine the need for continued treatment.

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death compared to placebo (4.5% vs. 2.6%, respectively). Seroquel (quetiapine fumarate) is not approved for the treatment of patients with dementia-related psychosis.

Prescribing should be consistent with the need to minimize the risk of tardive dyskinesia. A rare condition referred to as neuroleptic malignant syndrome has been reported with this class of medications, including Seroquel.

Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics, including Seroquel. Patients starting treatment with atypical antipsychotics who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.

Precautions include the risk of seizures, orthostatic hypotension, and cataract development.

The most commonly observed adverse events associated with the use of Seroquel in clinical trials were somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain, postural hypotension, pharyngitis, SGPT increase, dyspepsia, and weight gain.

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Seroquel immediate release tablets are approved for dosing two to three times per day. In schizophrenia, dosing should be increased gradually to 300-400 mg/day by the fourth day. In the elderly and in patients with hepatic impairment, consideration should be given to a lower starting dose, a slower rate of dose titration, careful monitoring during the initial dosing period, and a lower target dose.

Source: AstraZeneca Press Release, AP

Last updated: 08/06

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