Alkermes plc (NASDAQ: ALKS) today announced the initiation of the pivotal clinical development program 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 comprehensive pivotal program, named FORWARD (Focused On Results With A Rethinking of Depression), includes a total of 12 studies, including three core phase 3 efficacy studies and nine supportive studies. The first FORWARD study, evaluating the onset of clinical effect, safety and tolerability of ALKS 5461 in approximately 60 patients with MDD, has begun, and the three core efficacy studies are expected to begin in mid 2014.
The FORWARD pivotal program will evaluate the safety and efficacy of ALKS 5461 in patients suffering from MDD who have had an inadequate response to commonly prescribed drugs, including selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). Alkermes expects to use safety and efficacy data from the FORWARD studies as the basis for a New Drug Application (NDA) to be submitted to the U.S. Food and Drug Administration (FDA), pending study results.
"With a novel mechanism of action and Fast Track designation from the FDA, ALKS 5461 is designed to offer a new treatment option for the millions of people with MDD with urgent unmet medical needs," stated Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. "The comprehensive FORWARD program incorporates state-of-the-art design elements for depression trials and will be conducted in collaboration with leading clinical investigators."