Sage Therapeutics, Biogen See Positive Results for Depression Treatment
February 16 2022 - 7:48AM
Dow Jones News
By Chris Wack
Sage Therapeutics Inc. and Biogen Inc. said a study in people
with major depressive disorder met the trial objectives,
demonstrating a rapid and statistically significant reduction in
depressive symptoms at day three and over the two-week treatment
period, achieving the primary and key secondary endpoints.
The companies said this significance was demonstrated at the
first measured time point, Day 3, with zuranolone 50 mg
co-initiated with an open-label standard of care
antidepressant.
The study also met its key secondary endpoint, with zuranolone
co-initiated with a standard of care ADT demonstrating a
statistically significant improvement in depressive symptoms
compared with ADT co-initiated with placebo, over the two-week
treatment period.
Zuranolone was generally well-tolerated, and no new safety
signals attributable to zuranolone were identified. In meeting its
pre-defined objectives, the study supports the potential of
zuranolone, when co-initiated with standard of care, to accelerate
the benefit of depression treatment compared with treatment with
antidepressants alone.
Sage said that including this most-recent study, zuranolone now
has six positive clinical studies, and the company remains on track
to start the rolling submission for a New Drug Application in MDD
early this year with completion targeted for the second half of
2022.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
February 16, 2022 07:33 ET (12:33 GMT)
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