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 firstname.lastname@example.org
(END) Dow Jones Newswires