RxTrials Institute Drug Pipeline Alert

AstraZeneca has submitted a supplemental new drug application to the FDA for once-daily Seroquel extended-release (XR) tablets to treat major depressive disorder (MDD).

MDD affects 15 million American adults and is often treated with antidepressants. Studies have shown that at least one-third of patients treated with antidepressants fail to achieve a satisfactory response, according to AstraZeneca.
 
The Seroquel XR (quetiapine fumarate) application is based on seven placebo-controlled Phase III studies that assessed the drug’s efficacy and safety. The studies evaluated the drug as a monotherapy, adjunct therapy and maintenance therapy.

The first four trials were acute monotherapy studies involving 2,116 patients. Studies 6 and 7 were acute adjunct therapy studies involving 939 patients who had an inadequate response to an antidepressant therapy. Study 5 was a longer-term monotherapy maintenance study involving 1,854 patients.