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MDD affects 15 million American adults -- between 5 and 8 percent of thepopulation each year -- and today it is often treated with generic or brandedantidepressants.(1) Studies have shown that at least one-third of patientswith MDD treated with antidepressants fail to achieve a satisfactoryresponse.(2) The American Psychiatric Association Practice Guidelinesrecommend switching to a medication in another class when two medications fromthe same class have proven ineffective.(3) AstraZeneca has investigated theuse of SEROQUEL XR, an atypical antipsychotic, in the treatment of MDD, aimingto develop another potential treatment option, including treatment forpatients who have failed or had an inadequate response to anotherantidepressant therapy.
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The MDD submission is based on seven Phase III, placebo-controlled studiesthat assessed the efficacy and safety of once-daily treatment with SEROQUEL XRin patients diagnosed with MDD. Studies 1, 2, 3, and 4 were acute monotherapystudies involving 2,116 patients; Studies 6 and 7 were acute adjunct therapystudies (with ongoing antidepressant therapy) involving 939 patients who hadan inadequate response to an antidepressant therapy; and Study 5 was alonger-term (up to 78 weeks) monotherapy maintenance study involving 1,854patients. The acute studies included in this submission used theMontgomery-Asberg Depression Rating Scale (MADRS)* as the primary assessmentof depression symptoms. In the longer-term study (Study 5), the primaryassessment was time to a depressed event using criteria including the MADRS.Doses of 50 mg, 150 mg and 300 mg of SEROQUEL XR were studied in the MDDprogram.(4)
In 2007, SEROQUEL XR was approved in the U.S. for the treatment ofschizophrenia in adult patients and for maintenance treatment of schizophreniain adult patients. Last month, AstraZeneca announced the submission of twoseparate sNDAs to the FDA for SEROQUEL XR to seek approval for the treatmentof manic episodes associated with bipolar disorder and the treatment ofdepressive episodes associated with bipolar disorder. The FDA has notcompleted its review of these submissions. In addition to the submission forMDD, clinical development programs are ongoing and regulatory filings areplanned for SEROQUEL XR in other indications.
Launched in 1997, SEROQUEL(R) (quetiapine fumarate tablets) has beenprescribed to millions of patients worldwide. It is approved in 88 countriesfor the treatment of schizophrenia, in 79 countries for the treatment ofbipolar mania, and in 11 countries including the U.S. for the treatment ofbipolar depression.
Important Safety Information for SEROQUEL and SEROQUEL XR
SEROQUEL XR is indicated for the acute and maintenance treatment ofschizophrenia. SEROQUEL is indicated for the treatment of depressive episodesin bipolar disorder; acute manic episodes in bipolar I disorder, as eithermonotherapy or adjunct therapy to lithium or divalproex; and schizophrenia.Patients should be periodically reassessed to determine the need for treatmentbeyond the acute response.
Elderly patients with dementia-related psychosis treated with atypicalantipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death,compared to placebo (4.5% vs 2.6%, respectively). SEROQUEL and SEROQUEL XRare not approved for the treatment of patients with dementia-relatedpsychosis. (See Boxed Warning.)
Antidepressants increased the risk of suicidal thinking and behavior inchildren, adolescents, and young adults in s
