‘We are extremely pleased to have been conferred Fast Track status for ALKS 5461 as we believe that ALKS 5461 may represent an important option for the treatment of main depressive disorder,’ said Elliot Ehrich, Chief Medical Officer of Alkermes. ‘This designation supports our placement that there is a obvious and compelling dependence on a novel mechanism for the treating depression.’.. Alkermes’ ALKS 5461 drug gets FDA Fast Monitor status for main depressive disorder Alkermes plc today announced that the U.S. Food and Medication Administration has granted Fast Track status for ALKS 5461 for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard therapies. Fast Track is a process designed to facilitate the development, and expedite the overview of drugs to treat serious conditions and with the potential to address an unmet medical need.Of these enrolled, one-third were enrolled in the last week of life. The evaluation also found that a significant number of patients didn’t receive appropriate administration of their discomfort or shortness of breath within their last two medical visits. ASCO’s policy declaration was released today in ASCO’s Journal of Clinical Oncology. It outlines essential elements of care for patients with advanced cancer and identifies barriers that currently prevent advance cancer care preparing conversations between physicians and patients.
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