Alderley Park, UK – AstraZeneca has announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for quetiapine (Seroquel) to be granted a licence for the treatment of acute mania associated with bipolar disorder (manic-depressive illness).
The application to the FDA follows the completion of a comprehensive clinical trial programme in bipolar disorder undertaken by AstraZeneca. The trials examined the efficacy and tolerability of quetiapine in the treatment of acute mania on two levels: as monotherapy (i.e to be prescribed on its own) and as adjunctive therapy with standard mood stabilising medication. These clinical trials have delivered strong and positive results in both the monotherapy and adjunctive therapy studies, which confirm quetiapine to be an ideal first line therapy for the treatment of acute mania associated with bipolar disorder.
“Quetiapine is destined to be an important treatment option for patients suffering from bipolar disorder” commented Dr. Gary Sachs from Harvard Medical School, Boston, and lead investigator on the studies. “Treatment compliance in bipolar disorder is particularly critical since patients may lead full and productive lives when stable while a relapse in symptoms can cause real difficulties. The ability of quetiapine to improve the symptoms of the disease while keeping side effects to a minimum, may improve quality of life and ultimately lead to greater compliance with medication, offering real benefits for patients and their families.”
The trial programme consisted of four studies involving almost 1000 patients in 28 countries. The results from one of the adjunctive therapy studies were presented earlier this year at the 3rd European Stanley Foundation Conference in Bipolar Disorder, in Germany1. The results from this trial showed that quetiapine, in combination with standard mood stabilising medication (lithium or divalproex), is significantly more effective at treating the acute mania associated with bipolar disorder than mood stabilisers alone. Importantly, the results also showed that quetiapine in combination with mood stabilisers is well tolerated – a major consideration in the treatment of this disorder. The results from the remaining monotherapy studies will be presented at major psychiatry conferences in 2003.
“We are very pleased with the results of the trial programme and are extremely optimistic about the future for Seroquel. Seroquel is a truly unique compound and its profile is ideal for the treatment of bipolar disorder” commented Geoff Birkett, Global Vice President, CNS, Pain and Infection. “Success in the market is driven by the impact on patients and our vision to introduce therapies that truly change patients’ lives for the better. With its expanded indication range, Seroquel will continue to help patients and is the cornerstone of our rapidly growing CNS business.”
Seroquel (quetiapine) is manufactured by AstraZeneca and is currently approved in over 75 markets. Seroquel combines broad-based efficacy in the treatment of positive, negative, cognitive and affective symptoms of schizophrenia, while offering excellent tolerability. Seroquel is associated with an incidence of EPS and prolactin elevation no different to placebo across the full dosage range, a favourable weight profile, and no clinically important effects on QT interval. To date, over 4 million people have been treated with Seroquel worldwide.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $16.4 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. In CNS, AstraZeneca is dedicated to providing medicines that offer the potential to change patients’ lives. The company already markets Seroquel, one of the fastest growing global antipsychotics with proven efficacy and a very favourable side effect profile; and Zomig, a reliable migraine therapy and a leader in the triptan market. AstraZeneca’s R&D pipeline also includes leading approaches for the treatment of depression and anxiety, overactive bladder, dementia and stroke.