SEROQUEL(r) Manages Depressive Symptoms and Minimizes Side Effects Common in Other Treatments

Market Wire, 20050229

SEROQUEL TABLETS AND ASTRAZENECA

Clinical trials with SEROQUEL have demonstrated efficacy in treating the positive and negative symptoms of schizophrenia. There were no differences from placebo across the clinical dose range in the incidence of EPS, including rigidity and difficulty starting and stopping movement, or elevation of plasma prolactin levels. In addition, studies have shown that SEROQUEL exhibits a low incidence of hormonal, reproductive (sexual dysfunction), and anticholinergic side effects (dry mouth, constipation).

In clinical trials, efficacy was demonstrated in a dose range of 150 mg/day to 750 mg/day. An initial target dose range of 300-400 mg can be given in two divided doses daily. The drug is manufactured in the United States by AstraZeneca and is available by prescription in strengths of 25-mg, 100-mg, and 200-mg tablets. Since its approval in September of 1997, in the United States there have been more than 1.2 million prescriptions written for SEROQUEL for more than 370,000 patients.6,7

The efficacy of SEROQUEL, as well as the atypical profile which distinguishes the compound from standard antipsychotic agents, is supported by several placebo- and comparator-controlled Phase II and III clinical trials in patients hospitalized for acute exacerbation of chronic or subchronic schizophrenia. SEROQUEL was well tolerated in more than 4,000 male and female patients 18 years and older. SEROQUEL is comparable to placebo with regard to EPS. No blood monitoring is required.

As with other agents in its class, the labeling for SEROQUEL Tablets includes a warning relative to a rare condition known as tardive dyskinesia (which is often associated with long-term use of antipsychotic agents) and neuroleptic malignant syndrome (NMS symptoms include muscle rigidity, fever, and irregular pulse). Precautions include orthostatic hypotension and the risk of cataract development. As with other antipsychotics, SEROQUEL therapy should be used cautiously in patients with a history of seizures or with conditions that can potentially lower the seizure threshold. The most common adverse events exhibited across placebo-controlled trials included headache (19%), somnolence (18%), and dizziness (10%), and the majority of events were rated mild or moderate. The safety and effectiveness of SEROQUEL in pediatric patients (less than 18 years of age) have not been established.

AstraZeneca PLC is one of the top five pharmaceutical companies in the world based on sales and is a therapeutic leader in gastrointestinal, oncology, anesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. Based in the United Kingdom, AstraZeneca PLC (NYSE:AZN) is a major $15.8 billion international bioscience business engaged in the research, development, manufacture, and marketing of ethical (prescription) pharmaceuticals and agricultural products, and the supply of health care services. The U.S. operations of AstraZeneca include AstraZeneca, a Business Unit of Zeneca Inc., AstraZeneca LP, Zeneca Ag Products and Salick Health Care. In the United States, AstraZeneca is a $7.2 billion bioscience business with approximately 11,000 employees.