Earlier, in December 2009, AstraZeneca and Targacept have signed a collaboration and license agreement for the development and commercialisation of TC-5214.
TC-5214 Phase 3 program, referred to as the Renaissance Program and is designed to support the planned second half of 2012 filing of a new drug application with the FDA for the drug as an adjunct treatment for major depressive disorder (MDD) in patients with an inadequate response to first-line therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin/norephinephrine reuptake inhibitor (SNRI). A marketing authorisation application in Europe is projected for 2014.
The Renaissance Program was designed to include two fixed dose Phase 3 studies and two flexible dose Phase 3 studies to evaluate the efficacy and tolerability of TC-5214 as an adjunct treatment in patients with an inadequate response to SSRI or SNRI therapy.
Additionally, the Renaissance Program includes a double blind, placebo controlled long-term safety study in which patients would receive TC-5214 or placebo for up to one year.
Each of the fixed dose and flexible dose Phase 3 studies includes an open label first phase in which patients diagnosed with MDD receive one of seven marketed SSRIs or SNRIs for eight weeks to determine the extent of therapeutic response.
The primary outcome measure for each study is change from double blind baseline for TC-5214 on the Montgomery-Asberg Depression Rating Scale (MADRS) as compared to placebo.