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AstraZeneca and Targacept Initiate Phase 3 Clinical Development of TC-5214 as an Adjunct Treatment for Major Depressive Disorder
AstraZeneca and Targacept, Inc., today announced the enrollment of the first patient in the Phase 3 clinical development program for TC-5214, a nicotinic channel blocker. The Phase 3 program, referred to as the Renaissance Program, is designed to support the planned second half of 2012 filing of a new drug application with the U.S. Food and Drug Administration for TC-5214 as an adjunct treatment for major depressive disorder (MDD) in patients with an inadequate response to first-line therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin/norephinephrine reuptake inhibitor (SNRI). A Marketing Authorisation Application in Europe is planned for 2014.
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