Alkermes plc (ALKS) Announces Initiation Of FORWARD-3 And FORWARD-4 Efficacy Studies In Pivotal Program For ALKS 5461 For Treatment Of Major Depressive Disorder
6/10/2014 9:50:03 AM
DUBLIN, Ireland--(BUSINESS WIRE)--Alkermes plc (NASDAQ: ALKS) today announced the initiation of FORWARD-3 and FORWARD-4, two of the three planned phase 3 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.1
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