FDA Gives OK for Schizophrenia Treatment

AstraZeneca PLC said Monday that it has received approval from the U.S. Food and Drug Administration for a new formulation of its popular Seroquel schizophrenia treatment, making it the first medicine to treat both the manic and depressive sides of bipolar disorder.

Seroquel, launched by the Anglo-Swedish company in 1997, is already used to treat acute manic episodes associated with bipolar disorder and schizophrenia. The FDA approval adds the treatment of patients with depressive episodes.

Seroquel is one of AstraZeneca's top-selling drugs, with total sales of $2.8 billion last year. The company has filed for similar regulatory approval in Canada and the European Union.

"Treating acute bipolar disorder with a single medication may help patients adhere to their medication regimen," said John Patterson, executive director of development for AstraZeneca.

About 7 million adult Americans have bipolar disorder, a condition that strikes people in their teens and late 20s and causes episodes of mania and depression.

Previous anti-psychotic drugs had side effects giving patients tremors and restlessness. Newer drugs such as Seroquel, Eli Lilly & Co.'s Zyprexa, Johnson & Johnson's Risperdal and Bristol-Myers Squibb Co.'s Abilify are intended to have fewer side effects and dominate a market worth around $16.2 billion.

The FDA decision to approve the new treatment in the United States was based on an eight-week study of 1,045 patients with bipolar depression.

Patients were randomly assigned to take Seroquel or a placebo containing no medicine. Those taking Seroquel showed greater improvement in bipolar depression symptoms, overall quality of life, and satisfaction related to functioning, the company said.

The new formulation involves a once-daily dose of the treatment. The current immediate-release formula tablets are approved for dosing two to three times a day.

AstraZeneca shares were 0.3 percent higher at 3,516 pence ($65.83) on the London Stock Exchange.