FDA approves extended release formulation of Seroquel for schizophrenia

WILMINGTON, Del. The Food and Drug Administration has approved once-daily Seroquel XR (quetiapine fumarate) Extended-Release Tablets for maintenance treatment of schizophrenia in adult patients, AstraZeneca said last week.

Schizophrenia patients experience high rates of symptom relapse, and as a result, there is an important need for long-term treatment options for schizophrenia to help reduce the risk of the recurrence of acute psychotic episodes.

In May, the FDA approved Seroquel XR for the acute treatment of schizophrenia in adult patients.

In the clinical trial supporting this approval, patients with schizophrenia who were treated with AstraZeneca’s new formulation experienced a significantly longer time to relapse, compared with patients receiving a placebo. Patients receiving the drug demonstrated an 84 percent reduction in the relative risk of relapse.

“Today’s FDA approval helps address the need for longer-term treatment options for patients with schizophrenia,” said Mark Scott, executive director for development at AstraZeneca. “The clinical trial results provided compelling evidence for reducing the risk of relapse when these patients are treated with Seroquel XR.”

The adverse reactions reported for Seroquel XR in the longer-term placebo-controlled schizophrenia trial were insomnia and headache. The adverse effects were generally consistent with those reported in the short-term placebo-controlled schizophrenia trials, AstraZeneca said.

Launched in 1997, Seroquel has been prescribed to millions of patients worldwide. It is approved in 88 countries for the treatment of schizophrenia, in 77 countries for the treatment of bipolar mania, and in 11 countries including the U.S. for the treatment of bipolar depression. The drug was launched for the treatment of schizophrenia in the U.S. in 2007, and clinical development programs and regulatory filings are planned for a number of other indications.