Biogen/Sage’s Zuranolone Data May Not Be Enough For Tough Commercial Landscape

Phase III Data Seen As Underwhelming

The drug may have enough efficacy for approval, but data fell short of the benchmark seen as necessary for commercial adoption.

DEPRESSION miserable depressed , Depression and its consequences, Depressed emotions concept , alone in depression - Image — Biogen/Sage announce results of WATERFALL study of zuranolone in major depressive disorder • Source: Shutterstock

Although Sage Therapeutics, Inc.’s Phase III WATERFALL trial of zuranolone in adults with major depressive disorder (MDD) was positive, the benefit seen and its adverse event profile have raised doubts about its clinical meaningfulness, even if the data are sufficient to warrant US Food and Drug Administration filing.

The antidepressant, an oral neuroactive steroid GABA-A receptor positive allosteric modulator, has been a major focus for the firm, which...