Date: 2012-03-20
Type of information:
phase: 3
Announcement: results - discontinuation of further development
Company: AstraZeneca (UK)
Product: TC-5214
Action mechanism:
Disease: major depressive disorder (MDD)
Therapeutic area: CNS diseases - Mental diseases
Country:
Trial details:
Latest
news: AstraZeneca and Targacept announced top-line results from the remaining Phase III studies investigating efficacy, tolerability and safety of TC-5214 as an adjunct therapy to an antidepressant in patients with major depressive disorder 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.
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 Programme for TC-5214.
Last December AstraZeneca has already announced that the second RENAISSANCE Phase III study of TC-5214 did not meet its primary end point (see http://biopharmanalyses.fr/clinical-trails/?pageid=392).
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. AstraZeneca will take an intangible asset impairment charge of $50 million, the remaining value in relation to TC-5214.
