All three core efficacy studies in FORWARD pivotal programme now underway for treatment of major depressive disorder
Alkermes has announced the initiation of FORWARD-5, the third of three core efficacy studies planned in the pivotal clinical programme 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 study will evaluate the efficacy and safety of ALKS 5461 in patients suffering from MDD who have had an inadequate response to commonly prescribed drugs for depression, including selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).
'Our FORWARD pivotal programme has strong momentum with all three of our planned core efficacy studies underway, and each incorporates state-of-the-art study design elements to reduce the impact of placebo response commonly observed in depression trials,' said Dr Elliot Ehrich, Chief Medical Officer of Alkermes. 'We are very enthusiastic about our robust clinical programme for ALKS 5461 as we evaluate the potential of its novel mechanism of action to treat MDD and offer a new option for the millions of people with unresolved depression.'
FORWARD-5 is a phase 3, multinational, randomised, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of ALKS 5461 as adjunctive treatment in approximately 500 patients with MDD. This study, along with the two other core efficacy studies already underway, FORWARD-3 and FORWARD-4, incorporates sophisticated design features to ensure rigorous patient selection, monitoring and evaluation. Data from these three core efficacy studies are expected in 2016.
Further information about the initiated FORWARD studies can be found at www.clinicaltrials.gov.