![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Major Depressive Disorder Drug Shows Promise in Trial
Major Depressive Disorder Drug Shows Promise in Trial
![Positive Results](https://www.fdanews.com/ext/resources/test/Drug-Images4/Postitive-Results.gif?t=1623701844&width=430)
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.
Upcoming Events
-
21Oct