Sage, Biogen's Zuranolone Meets Primary Endpoint in Phase 3 Trial
15 June 2021 - 9:09PM
Dow Jones News
By Matt Grossman
Sage Therapeutics Inc. and Biogen Inc. said Tuesday that their
zuranolone drug's 50 mg dose met the primary endpoint in a Phase 3
trial.
The drug led to a statistically significant improvement in
major-depressive symptoms compared with a placebo, Sage and Biogen
said. Zuranolone is taken once daily and could potentially provide
a fast-acting and sustainable treatment option for depression, the
companies said.
The study included 543 patients aged 18 to 64. Their symptoms
were measured using the Hamilton rating scale for depression.
The most common adverse events among people treated with
zuranolone in the study were sleepiness, dizziness, headache and
sedation, the companies said. About 3% of subjects stopped taking
the drug because of adverse effects, the companies said.
Sage and Biogen said that they plan to discuss next steps toward
regulatory approval with the Food and Drug Administration.
Write to Matt Grossman at matt.grossman@wsj.com
(END) Dow Jones Newswires
June 15, 2021 07:00 ET (11:00 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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