Alkermes initiates Phase III studies for ALKS 5461 for major depressive disorder

Alkermes plc announced the initiation of FORWARD-3 and FORWARD-4,two of the three planned Phase III core efficacy studies in the pivotal clinical program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD). These studies will evaluate the efficacy and safety of ALKS 5461 in patients suffering from MDD who have had an inadequate response to commonly prescribed drugs, including selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).

Approximately two-thirds of patients who are diagnosed with MDD do not adequately respond to initial antidepressant therapy. The two studies combined are expected to randomize approximately 1,000 patients and incorporate sophisticated design features to ensure rigorous patient selection, monitoring and evaluation. Data from these two core efficacy studies are expected to initiate in 2014.