FORWARD-5, the third primary efficacy trial, is likely to initiate in mid 2014.. Alkermes initiates Forwards-4 and Forwards-3 efficacy studies in pivotal clinical program for ALKS 5461 Alkermes plc today announced the initiation of Forwards-3 and Forwards-4, two of the three planned phase 3 core efficacy studies in the pivotal clinical program for ALKS 5461, a once-daily, oral investigational medication with a novel system of actions for the adjunctive treatment of main depressive disorder . These studies will evaluate the efficacy and safety of ALKS 5461 in patients suffering from MDD who have acquired an inadequate response to typically prescribed medicines, including selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors .Now that clinical trial is performed. And, it shows that for most atrial fibrillation sufferers, bridging with heparin is normally unnecessary, Ortel said. In fact, the study found, bridging with heparin seems to raise the risk of major inner bleeding – – without the reduction in the chance of blood clots. For years, we’ve believed that bridging will be beneficial, stated Dr. Alfonso Tafur, a vascular medication expert at NorthShore University Health System, in Chicago. But this study shows that in most of patients, bridging puts them at needless risk, said Tafur, who was simply not mixed up in extensive research.