They are treatments administered daily, which require sufficient exposure and continuous use to maintain effect. Monoamine-based antidepressants have been the standard of care for chronic treatment of MDD for the past 60 years. LS means (SE) change from baseline in HAMD-17 total score at Day 15 for patients who received zuranolone 50 mg was -14.1 (0.51) compared with -12.3 (0.50) for patients who received placebo (LS mean difference -1.7 points p=0.0141).
(Nasdaq: BIIB) today announced that the WATERFALL Study in patients with MDD met its primary endpoint with zuranolone (SAGE-217/BIIB125) 50 mg showing statistically significant improvement in depressive symptoms compared with placebo at Day 15 as assessed by the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score. Zuranolone is an investigational two-week, once-daily oral drug for MDD that represents a potential new class of drug for the management of this common but serious mental health disorderĬAMBRIDGE, Mass., J(GLOBE NEWSWIRE) - Sage Therapeutics, Inc.Zuranolone was generally well-tolerated and demonstrated a safety profile consistent with previous clinical studies trial completion rate was 90.3% in the zuranolone group.Patients with a response at Day 15 to zuranolone retained on average 86% of their HAMD-17 improvement at Day 42 (4 weeks after dosing ended).
Rapid onset of treatment effect was seen in HAMD-17 results at Days 3, 8, and 12.At the Day 15 primary endpoint, zuranolone 50 mg showed a statistically significant and clinically meaningful reduction in depressive symptoms as measured by HAMD-17 (p=0.0141) compared to placebo.Participant meets the following criteria for MCI or mild dementia due to AD at Screening: has a memory complaint, has clinical dementia rating (CDR) score of 0.5 to 1.0 (inclusive) with a memory box score ≥0.Why Should I Register and Submit Results?.
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