AstraZeneca (AZN), Targacept (TRGT) Will Not File for TC-5214 as Adjunct Treatment for MDD Patients
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AstraZeneca (NYSE: AZN) and Targacept, Inc. (Nasdaq: TRGT) announced top-line results from the remaining Phase 3 studies investigating efficacy, tolerability and safety of TC-5214 as an adjunct therapy to an antidepressant in patients with major depressive disorder (MDD) who did not respond adequately to initial antidepressant treatment. RENAISSANCE 4 and RENAISSANCE 5, both efficacy and tolerability studies, did not meet the primary endpoint of change on the Montgomery-Asberg Depression Rating Scale (MADRS) total score after eight weeks of adjunct treatment with TC-5214 as compared to placebo.
In both RENAISSANCE 4 and RENAISSANCE 5, as well as in the previously completed RENAISSANCE 2 and RENAISSANCE 3 studies, every dose group (TC-5214 and placebo) showed at least a 40 percent improvement in MADRS total score after eight weeks of adjunct treatment. TC-5214 was overall well tolerated in RENAISSANCE 4 and RENAISSANCE 5 with an adverse event profile generally consistent with prior clinical trials.
In RENAISSANCE 7, a long-term study designed primarily to evaluate the safety of TC-5214, together with an antidepressant treatment, for one year, TC-5214 was overall well tolerated, with an adverse event profile generally consistent with prior clinical trials.
These studies conclude the RENAISSANCE Program for TC-5214. Based on the totality of the results, AstraZeneca and Targacept will not pursue a regulatory filing for TC-5214 as an adjunct treatment for patients with MDD.
In both RENAISSANCE 4 and RENAISSANCE 5, as well as in the previously completed RENAISSANCE 2 and RENAISSANCE 3 studies, every dose group (TC-5214 and placebo) showed at least a 40 percent improvement in MADRS total score after eight weeks of adjunct treatment. TC-5214 was overall well tolerated in RENAISSANCE 4 and RENAISSANCE 5 with an adverse event profile generally consistent with prior clinical trials.
In RENAISSANCE 7, a long-term study designed primarily to evaluate the safety of TC-5214, together with an antidepressant treatment, for one year, TC-5214 was overall well tolerated, with an adverse event profile generally consistent with prior clinical trials.
These studies conclude the RENAISSANCE Program for TC-5214. Based on the totality of the results, AstraZeneca and Targacept will not pursue a regulatory filing for TC-5214 as an adjunct treatment for patients with MDD.
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