In addition, Alkermes’ Phase III program for ALKS 5461, a Fast Track-designated drug being evaluated for the treatment of major depressive disorder (MDD) in patients who have had an inadequate response to standard therapies, is expected to begin in 1Q14.
“As we begin 2014, Alkermes is aggressively executing on our strategy of building and advancing one of the most exciting CNS pipelines in the industry; one characterized by its potential value to patients and treatment systems,” said Richard Pops, chief executive officer of Alkermes.
“Schizophrenia and major depressive disorder are chronic diseases that affect the daily lives of millions of patients and are conditions where new treatment options with novel mechanisms of action and new dosing regimens are needed,” said Elliot Ehrich, M.D., chief medical officer of Alkermes. “Clinicians who treat patients with schizophrenia and major depression need better treatment options to achieve stable remission in these serious, chronic conditions. Our goal is to advance clinical care by addressing unmet medical needs with aripiprazole lauroxil and ALKS 5461.”