Supernus Announces Promising Data from Open-Label Phase 2a Study of SPN-820 in Adults with Major Depressive Disorder

Core Insights - Supernus Pharmaceuticals announced positive results from its Phase 2a clinical study of SPN-820, a novel treatment for major depressive disorder, demonstrating a rapid and substantial decrease in depressive symptoms [1][3] - The company plans to host a webcast to discuss the topline data and expects to release results from a Phase 2b study in the first half of 2025 [1][3] Study Results - The Phase 2a study involved 40 subjects, with 38 completing the treatment, showing a clinically meaningful improvement of -6.1 at two hours and -9.6 at Day 10 on the Hamilton Depression Rating Scale-6 Items (HAM-D6) [2][6] - On the Montgomery Åsberg Depression Rating Scale (MADRS), improvements of -16.6 at four hours and -22.9 at Day 10 were observed [2] - Suicidal ideation decreased by 80%, from 12.5% at baseline to 2.6% at Day 10 [2] Safety and Tolerability - SPN-820 was well-tolerated, with a low discontinuation rate of 2.5% due to adverse events [2] - Common adverse events included headache, nausea, somnolence, and dizziness, with additional events such as cognitive disorder and dry mouth reported [2] Product Overview - SPN-820 is a first-in-class, orally active small molecule that enhances synaptic function via mTORC1 modulation, aiming for rapid antidepressant effects without dissociative side effects [5] - The ongoing Phase 2b study will involve approximately 227 adult patients with treatment-resistant depression [5]