Company unveils new Aripiprazole Lauroxil two-month product candidate for treatment of schizophrenia; clinical testing to begin in 2014
Alkermes has announced new developments related to its late-stage product candidates in its proprietary central nervous system (CNS) pipeline.
The company unveiled aripiprazole lauroxil two-month, a new product candidate addition to its portfolio of atypical antipsychotics for the treatment of schizophrenia. If approved, aripiprazole lauroxil two-month would be the first and only long-acting atypical antipsychotic medication dosed every two months. This new two-month product candidate is designed to provide physicians and patients with an even longer dosing option than the once-monthly formulation of aripiprazole lauroxil, which is currently completing the phase 3 study, with topline results expected in the first half of 2014.
In addition, Alkermes provided details regarding its pivotal phase 3 programme for ALKS 5461, a Fast Track-designated new medicine being evaluated for the treatment of major depressive disorder (MDD) in patients who have had an inadequate response to standard therapies. The phase 3 trials for ALKS 5461 will incorporate state-of-the-art study designs, and the pivotal program is expected to begin in the first quarter of 2014.
'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 characterised 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, 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.'