Posted by Michael Wonder on 31 Jan 2018
Alkermes submits new drug application to U.S. FDA for ALKS 5461 for the adjunctive treatment of major depressive disorder
31 January 2018 - New medicine for treating major depressive disorder supported by comprehensive efficacy and safety data package from more than 1,500 patients.
Alkermes today announced that it has submitted a new drug application to the U.S. FDA for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD). The submission is based on a comprehensive clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 patients with MDD. Throughout the clinical development program, ALKS 5461 demonstrated a consistent profile of anti-depressant activity, safety and tolerability in the adjunctive treatment of MDD.
ALKS 5461 was granted fast track status by the FDA in October 2013 for the adjunctive treatment of MDD in patients with an inadequate response to standard anti-depressant therapies.
