Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.AstraZeneca has reported the submission of a supplemental new drug application or sNDA to the FDA for once- daily Seroquel XR extended-release tablets to seek approval for the treatment of major depressive disorder or MDD as monotherapy, adjunct therapy, and maintenance therapy in adult patients.
Subscribe to our email newsletter
The MDD submission is based on seven Phase III, placebo-controlled studies that assessed the efficacy and safety of once-daily treatment with Seroquel XR in patients diagnosed with MDD. The acute studies included in this submission used the Montgomery-Asberg Depression Rating Scale (MADRS) as the primary assessment of depression symptoms. In the longer-term study, the primary assessment was time to a depressed event using criteria including the MADRS. Doses of 50mg, 150mg and 300mg of Seroquel XR were studied in the MDD program.
AstraZeneca has investigated the use of Seroquel XR, an atypical antipsychotic, in the treatment of MDD, aiming to develop another potential treatment option, including treatment for patients who have failed or had an inadequate response to another antidepressant therapy. In addition to the submission for MDD, clinical development programs are ongoing and regulatory filings are planned for Seroquel XR in other indications.