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AZ pushes on with depression drug despite missing phase III endpoint

Plans first filing in 2012 for potential first-in-class treatment TC-5214

AstraZeneca (AZ) is still planning to file its potential first-in-class depression treatment for approval next year, despite TC-5214 missing its primary endpoint in a phase III trial.

The nicotinic channel modulator is being studied as a treatment for major depressive disorder (MDD) and AZ, along with development partner Targacept, has just released the first results of its phase III RENAISSANCE 3 trial.

These show TC-5214 did not meet its primary endpoint of change on the Montgomery-Asberg Depression Rating Scale (MADRS), a widely used psychiatric questionnaire, compared to placebo after eight weeks of treatment.

Full results from the full RENAISSANCE programme will be reported in the first half of 2012 and AZ remains committed to the drug's development, planning to file TC-5214 for US approval in the second half of 2012 and to send it to European regulators in 2015.

The RENAISSANCE 3 trial involved 780 patients with MDD, with 624 initially receiving one of seven SSRIs or SNRIs on an open label basis for eight weeks to determine the extent of therapeutic response.

At the end of the eight weeks, 295 patients who did not respond adequately, based on predefined criteria, were randomised into the double blind phase of the study and received either a flexible dose of TC-5214 or placebo, twice daily, while continuing the SSRI or SNRI therapy for an additional eight weeks.

The dosage of TC-5214 was initially 2 mg/day and could be increased at the discretion of the investigator to 4 mg/day and 8 mg/day based on tolerability and therapeutic response.

The full RENAISSANCE programme consists of four randomised, double blind, placebo controlled phase III efficacy and tolerability studies and a fifth long-term safety study.

TC-5214 is being developed as an adjunct treatment for major depressive disorder in patients with an inadequate response to antidepressant therapies, such as selective serotonin reuptake inhibitors (SSRIs) like GlaxoSmithKline's Seroxat or serotonin/norephinephrine reuptake inhibitors (SNRIs) like Lilly's Cymbalta.

8th November 2011

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