Anticipated Phase 3 Interim Results for Sage’s Depression Treatment, Zuranolone

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Sage Therapeutics, Inc. recently released the clinical study results for zuranolone (SAGE-217) for the treatment of depression. The study tested the safety and tolerability of zuranolone 30 mg in patients aged 18 to 75 years with major depressive disorder (MDD). Almost half of all trial participants who positively responded to the initial 14-day course of zuranolone 30 mg did not require additional treatment to maintain wellness through a year of follow up.

“This data from the SHORELINE Study show that medically-oriented, as needed treatment for depression has the potential to be a compelling option for many patients diagnosed with MDD,” Jeff Jonas, MD, chief executive officer at Sage Therapeutics, said to press. “Approximately 70% of patients who participated in the study only needed one or two treatment courses, a total of two to four weeks of treatment with zuranolone 30 mg, which we believe will be the minimally effective dose, if our development efforts are successful.”¹

Data analyzation indicates zuranolone was well-tolerated in the 30 mg dose, and the reported adverse events were generally consistent with previous clinical trial results. The most common adverse events were somnolence (9.5%), headache (8.7%), and dizziness (5.4%). Those who needed retreated saw similar safety, tolerability, and efficacy results to those seen in the initial treatment course.

Out of the 494 patients continuing in the study, 220 (44.5%) patients received only a single initial zuranolone course. Around 132 patients (26.7%) used a total of 2 courses, while 66 (13.4%) used a total of 3 courses, and 51 (10.3%) used a total of 4 courses. Only 27 (5.5%) used a total of 5 courses.

A sample of patients were retreated with a 50 mg dose of zuranolone. Higher rates and levels of intensity of adverse events were reported, although most were of mild or moderate intensity. A new cohort of patients simultaneously began their treatment with zuranolone 50 mg. In this group, the adverse event profile was similar to that of the 30 mg patients. Events included somnolence, dizziness, sedation, headache, and tremor, but most were mild or moderate. 

Sage plans to release comprehensive data from the 30 mg dose in early 2021.

Reference

1. Sage Therapeutics Announces Positive Interim, Topline Zuranolone Safety and Tolerability Data from Open-Label SHORELINE Study in Patients with MDD. Press release. Business Wire. October 15, 2020. https://www.businesswire.com/news/home/20201015005330/en/Sage-Therapeutics-Announces-Positive-Interim-Topline-Zuranolone-Safety-and-Tolerability-Data-from-Open-Label-SHORELINE-Study-in-Patients-with-MDD​