Positive outcomes had been announced from a phase 3 study evaluating zuranolone (SAGE-217/BIIB125) for the remedy of adults with key depressive disorder (MDD).
Zuranolone is an investigational oral neuroactive steroid GABA-A receptor positive allosteric modulator that is administered when every day for 2 weeks. The double-blind, randomized, placebo-controlled WATERFALL study (ClinicalTrials.gov Identifier: NCT04442490) integrated 543 adults 18 to 64 years of age with MDD.
Patients had been randomly assigned to obtain either zuranolone 50mg or placebo when every day for 14 days. The principal endpoint was the transform from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score at day 15. Key secondary endpoints integrated the transform from baseline to day 15 in the Montgomery-Åsberg Depression Rating Scale (MADRS), the Hamilton Anxiety Rating Scale (HAM-A) total score, and the Clinical Global Impression-Improvement (CGI-I) Response.
Results showed that at day 15, patients in the zuranolone remedy arm demonstrated a statistically important and clinically meaningful improvement in depressive symptoms as measured by HAMD-17 total score (LS imply distinction, -1.7 points P =.0141). Patients with a response at day 15 retained on typical 86% of their HAMD-17 improvement at day 42 (4 weeks soon after dosing ended).
Zuranolone was also connected with important improvements in essential secondary endpoints like MADRS (LS imply distinction, -2.4 P =.0238), HAM-A (LS imply distinction, -1.4 P =.0199), and CGI-I response (odds ratio, 1.5 P =.0191).
The most frequent remedy emergent adverse events observed in patients treated with zuranolone compared with placebo integrated somnolence (15.3% vs 3%), dizziness (13.8% vs 2.2%), headache (10.8% vs 7.8%), and sedation (7.5% vs .4%). There had been no signals for withdrawal symptoms or for improved suicidal ideation or behavior.
Additional information from the WATERFALL study will be presented at a future healthcare meeting.
Sage Therapeutics and Biogen announce positive pivotal phase 3 outcomes for zuranolone, an investigational two-week, when-every day therapeutic becoming evaluated for key depressive disorder. [press release]. Cambridge, MA: Sage Therapeutics, Inc and Biogen Inc. June 15, 2021.
This write-up initially appeared on MPR