Supernus Pharmaceuticals Inc. (SUPN) has unveiled promising results from its exploratory open-label Phase 2a clinical trial evaluating SPN-820 in adults with major depressive disorder. This study explored both the safety and tolerability of administering 2400 mg of SPN-820 every three days as a supplementary treatment to existing antidepressant therapies, while also assessing the rapid onset of symptomatic improvements in depression.
The trial involved 40 participants, and 38 completed the designated 10-day treatment regimen. The findings reveal a significant clinical improvement in depression metrics, marked by a reduction of -6.1 at the two-hour mark and -9.6 by Day 10, according to the Hamilton Depression Rating Scale-6 Items (HAM-D6). Similarly, the Montgomery Asberg Depression Rating Scale (MADRS) recorded a substantial decline of -16.6 at four hours and -22.9 by Day 10.
Furthermore, there was an 80% reduction in suicidal ideation, as the proportion of participants reporting such thoughts fell from 12.5% at the study’s start to 2.6% by Day 10.
SPN-820 was generally well-tolerated, with a low adverse event-related discontinuation rate of 2.5%. The most frequently reported side effects included headache, nausea, somnolence, and dizziness. Additional side effects observed were cognitive disorder, dry mouth, fatigue, nasal decongestion, and oral paresthesia.
