(Reuters) – Sage Therapeutics and Biogen Inc said their drug in combination with a standard of care antidepressant met the main goal of showing rapid and significant reduction in depressive symptoms in a late-stage study.
The drug, zuranolone, also met the study’s secondary goal of showing an improvement in symptoms when administered with a standard of care antidepressant, compared to a combination of placebo and antidepressants over a two-week period, the drugmakers said on Wednesday.
Sage plans to start submitting data for U.S. approval of the drug for major depressive disorder on a rolling basis early this year and is aiming to complete the application by the second half of the year.
In the study, zuranolone was generally well-tolerated with no new safety concerns, the companies said.
(Reporting by Amruta Khandekar; Editing by Amy Caren Daniel)
