Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.AstraZeneca and Targacept have reported the first top-line results from the Renaissance Phase III studies that assessed the efficacy and tolerability of TC-5214 as an adjunct therapy to an antidepressant in patients with major depressive disorder (MDD).
Subscribe to our email newsletter
TC-5214, a nicotinic channel modulator serves as an adjunct treatment for MDD in patients with an inadequate response to initial antidepressant therapies.
The Renaissance clinical trial programme consists of four randomised, double blind, placebo controlled Phase III efficacy and tolerability studies and a fifth long-term safety study.
According to the companies, the trial did not meet its primary endpoint of change on the Montgomery-Asberg Depression Rating Scale (MADRS) after eight weeks of treatment with TC-5214 as compared to placebo.
However, the drug candidate was found to be well tolerated and showed an adverse event profile generally consistent with the earlier Phase IIb study.
AstraZeneca and Targacept signed a collaboration and license agreement for the global development and commercialisation of TC-5214 in December 2009 .