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Second phase-3 study of TC-5214 did not meet primary endpoint


WINSTON-SALEM, N.C. — AstraZeneca and Targacept released results of the second of four phase-3 clinical trials that investigated the efficacy and tolerability of a drug that could serve as an adjunct therapy to major depressive disorder patients that had an inadequate response to initial antidepressant therapies.

The drug makers noted that the study did not meet its primary endpoint of change after eight weeks of treatment with TC-5214, compared with placebo. In this study, TC-5214 overall was well tolerated in the second study of the Renaissance program and showed an adverse event profile "generally consistent" with prior clinical trials of TC-5214.

The study results were in line with the first Renaissance study conducted by AstraZeneca and Targacept.

The two remaining efficacy studies in the program for TC-5214 are fixed dose trials, the companies noted.

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