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news.AstraZeneca and Targacept have announced top-line results from the remaining Phase III studies of TC-5214 as an adjunct therapy to an antidepressant in patients with major depressive disorder (MDD).
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In RENAISSANCE 4 and RENAISSANCE 5, efficacy and tolerability studies, patients did not respond adequately to initial antidepressant treatment.
The 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.
TC-5214 was overall well tolerated with an adverse event profile generally consistent with prior clinical trials.
The companies will not pursue a regulatory filing for TC-5214 as an adjunct treatment for patients with MDD and AstraZeneca will take an intangible asset impairment charge of $50m, the remaining value in relation to TC-5214.