Alkermes plc submitted a new drug application to the U.S. Food and Drug Administration for ALKS 5461 as an adjunctive treatment of major depressive disorder.
Major depressive disorder is a condition in which patients exhibit depressive symptoms in daily activities consistently for at least a two-week period and demonstrate impaired social, occupational, educational or other important functioning.
An adjunct therapy is another treatment used together with the primary treatment.
ALKS 5461 was granted fast-track status by the FDA in October 2013 for the same treatment usage in patients with an inadequate response to standard antidepressant therapies.
The application is based on a comprehensive clinical efficacy and safety package with data from more than 30 clinical trials involving patients with the disorder.
