The comprehensive pivotal plan medical articles.
Alkermes initiates pivotal clinical advancement plan for treatment of MDD Alkermes plc 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 . The comprehensive pivotal plan, named FORWARD , carries a total of 12 studies, including three primary phase 3 efficacy research and nine supportive studies. The first FORWARD study, evaluating the onset of scientific effect, safety and tolerability of ALKS 5461 in approximately 60 individuals with MDD, has begun, and the three primary efficacy studies are expected to begin with in mid 2014 medical articles .
Other conditions that can result in impaired vision and so are also associated with the accumulation of supplement A aggregates can also be resolved, including Best’s disease and certain forms of retinitis pigmentosa and of cone rod dystrophy. ‘We’ve developed a modified vitamin A with the hope of halting vision loss or even restoring ocular function,’ Dr. Washington says. ‘Humans have evolved to utilize natural micronutrients or vitamin supplements that regulate a multitude of physiological features. By altering the chemical substance structure of the vitamins, we are able to potentially regulate or improve the biological procedures that they control.’ Dr.