More positive news from Sage regarding their allopregnanolone-based treatment for depression. Looks promising.
Zuranolone is a two-week, once-daily oral drug under investigation for the treatment of MDD. It is a molecule that is designed to potentially provide a rapid-acting, sustainable treatment option.
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.
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).
No signal for withdrawal symptoms as assessed by the 20-item Physician Withdrawal Checklist (PWC-20), or for increased suicidal ideation or behavior as per the Columbia-Suicide Severity Rating Scale (C-SSRS) were identified.