AstraZeneca, Targacept: TC-5214 'well-tolerated,' did not meet endpoint in phase-3 trial
NEW YORK — AstraZeneca and Targacept released results of the first 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 said that while the drug was "well-tolerated" among study subjects, the study did not meet its primary endpoint of change after eight weeks of treatment with TC-5214, compared with placebo. The study was part of the Renaissance clinical trial program, which consists of four randomized, double-blind, placebo-controlled phase-3 studies and a fifth long-term safety study.
A new drug application for TC-5214 is expected to be filed in the United States during the second half of 2012.