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AstraZeneca announced that the company has submitted applications in the European Union (EU) for once-daily SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets (quetiapine XR), seeking approval for the treatment of major depressive disorder (MDD) including maintenance therapy in adult patients using Mutual Recognition Procedure (MRP). This follows an sNDA submission for SEROQUEL XR in MDD in the U.S. in February this year.
Each year, around 33 million people will suffer from MDD in Europe1 - between 3 and 10% of the population2. Today, it is treated with generic or branded antidepressants, including SSRIs (selective serotonin reuptake inhibitors) and SNRIs (serotonin norepinephrine reuptake inhibitors). Studies have shown at least one-third of patients fail to achieve a satisfactory response with current antidepressant therapy3. SEROQUEL XR is the first atypical antipsychotic medicine to be submitted in Europe for approval for the treatment of MDD. AstraZeneca has investigated its use in MDD as a potential new treatment option for patients who do not respond adequately to current treatments.
Data from eight randomized placebo-controlled studies of quetiapine XR at once-daily doses of 50, 150 and 300 mg in patients diagnosed with MDD support the submission announced today. These include four short-term monotherapy studies involving 2116 patients; two short-term adjunct therapy studies (with ongoing antidepressant therapy) involving 939 patients who had an inadequate response to prior antidepressant therapy; a longer-term monotherapy maintenance study involving 1,854 patients and up to 78 weeks of treatment; and a further short-term study involving 338 elderly patients. Buy amoxil without prescription The short-term studies used the Montgomery-?