‘Double boost’ for Seoquel in bipolar disorder and dementia
pharmafile | August 4, 2004 | News story | |Â Â Â
AstraZeneca announced a 'double boost' for its atypical antipsychotic Seroquel as it gained FDA approval for the long-term treatment of bipolar disorder and also showed strong potential as a treatment for dementia.
The approval, the first in its class, extends the treatment period from three to 12 weeks, giving it an advantage over Lilly's Zyprexa and Johnson & Johnson's Risperdal, the leading atypical products.
Seroquel achieved the fastest growth of all three products in 2003 with a 30% jump in sales and the new extended indication is likely to help it to further close the gap on its rivals.
The FDA approval is based on a trial of 599 patients which showed about two-thirds of patients receiving Seroquel monotherapy experienced significant improvement in manic symptoms and achieved remission after 12 weeks.
"For patients with bipolar disorder and their clinicians, it's important to know that Seroquel is not only effective in reducing symptoms of acute mania the first few weeks, but is also effective in the subsequent 'continuation phase' when patients can still have significant symptoms and are still at risk for relapsing," said Jamie Mullen, senior director of clinical research, AstraZeneca. "These data demonstrate that Seroquel treatment alone works early and continues to work through 12 weeks. For patients coping with this illness, this is good news."
Extending the efficacy period is important as patient compliance is a problem in the treatment of bipolar disorder, with more than 50% of sufferers stopping medication at some point during their illness, resulting in a high risk of relapse and nearly one in five patients committing suicide.
The other boost came from positive results presented at the International Conference on Alzheimer's Disease and Related Disorders, the 333 patient STAR study showing the drug may be an effective option for the treatment of agitation associated with dementia, including Alzheimer's disease, in elderly patients.
Commenting on the results Dr Pierre Tariot, professor of psychiatry, medicine and neurology at the University of Rochester, said: "These new study results are helpful, informative, and justify further investigation of Seroquel for agitation in dementia patients."
