www.fdanews.com/articles/203180-major-depressive-disorder-drug-shows-promise-in-trial
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Major Depressive Disorder Drug Shows Promise in Trial
June 16, 2021
Sage Therapeutics and Biogen reported that their investigational antidepressant drug, zuranolone, reduced depression vs. placebo after two weeks in a late-stage study.
A steroid that belongs to a class of drugs known as monoamine-based antidepressants, zuranolone works by modulating neurotransmitters that regulate communication between brain cells.
The phase 3 trial, which is evaluating the treatment in 543 adults with major depressive disorder, found that zuranolone achieved a change in the 17-item Hamilton Depression Rating Scale score of -14.1 points over 15 days, compared with -12.3 points in the placebo arm.
The drug, which has received FDA Breakthrough Therapy designation, is also being evaluated for treating postpartum depression.