MEB approves AstraZeneca's extended-release drug for schizophrenia
Efforts to improve the treatment of schizophrenia moved a step closer this week as approval was awarded to an extended-release tablet developed by AstraZeneca.
Efforts to improve the treatment of schizophrenia moved a step closer this week as approval was awarded to an extended-release tablet developed by AstraZeneca.
The once-daily SEROQUEL XR (quetiapine fumarate) medicine aims to improve dosing and titration options for patients and their doctors.
Approval was awarded by the Netherlands" Medicines Evaluation Board (MEB) and includes relapse prevention in the long-term treatment of this severe mental disorder.
Approval was based on clinical trials of the drug, which evaluated effectiveness and safety at doses of 400, 600, and 800 mg/day, in acute treatment, relapse prevention and also in a non-inferiority study of acute efficacy and safety when switching from the original formulation to SEROQUEL XR.
It is estimated that the drug has been used to treat more than 19 million patients worldwide since its launch in 1997.
Rene Kahn, professor and chair of the department of psychiatry and head of the division of neuroscience at the University Medical Center, Utrecht, said:
"In clinical studies SEROQUEL XR(TM) showed its potential as a once-daily treatment for both acute and clinically stable schizophrenia patients. In the clinical trials, the effective dose range was reached within two days of starting treatment - the data demonstrated that range is between 400 and 800 mg/day.'
SEROQUEL XR was approved for the treatment of schizophrenia in the US in May 2007. AstraZeneca will seek similar approvals from countries across Europe.
Other clinical studies using SEROQUEL XR cover bipolar disorder, major depressive disorder and generalised anxiety disorder.