Policy & Regulation
Sage Therapeutics and Biogen report positive 12-month data in ongoing Phase 3 open-label SHORELINE Study of Zuranolone 50mg in MDD patients
1 December 2021 -

Biopharmaceutical company Sage Therapeutics Inc (Nasdaq: SAGE) and neuroscience company Biogen Inc (Nasdaq: BIIB) on Wednesday reported 12-month data for the cohort of major depressive disorder (MDD) patients (n=199), who received zuranolone 50mg once nightly for 14-days as their initial dose in the ongoing Phase 3 open-label SHORELINE Study.

Zuranolone is a once-daily, two-week, investigational drug in development for the treatment of MDD and postpartum depression (PPD). The drug is an investigational oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM).

The SHORELINE Study, part of the LANDSCAPE clinical program, was designed to naturalistically follow adult patients with MDD and evaluate the safety and tolerability of zuranolone as well as the need for repeat dosing for up to one year.

With a primary endpoint of safety and tolerability, the data analyzed to date show zuranolone was generally well-tolerated, with no new safety findings or trends identified in the long-term safety data available regardless of the number of courses of zuranolone a patient received.

According to the companies, MDD is a common but serious mood disorder with depressive symptoms that impair sufferers' social, occupational, educational functioning, as well as a depressed mood or loss of interest or pleasure in daily activities, consistently for at least a two-week period. Approximately 19 million people in the US and over 250 million people worldwide suffer from MDD each year.

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