Supernus Announces Promising Data From Phase 2a Study Of SPN-820 In Major Depressive Disorder

(RTTNews) - Supernus Pharmaceuticals Inc. (SUPN) announced a promising data from its exploratory open-label Phase 2a clinical study of SPN-820 in adults with major depressive disorder.

The study examined the safety and tolerability of SPN-820 2400 mg given once every 3 days as an adjunctive treatment to the current baseline antidepressant therapy, as well as assessed the rapid onset of improvement in depressive symptoms. The analysis is based on 40 enrolled subjects, of which 38 completed the 10-day treatment period.

The data indicate a clinically meaningful improvement in depression scores, with a reduction of -6.1 at two hours and -9.6 at Day 10 on the Hamilton Depression Rating Scale-6 Items (HAM-D6). Similarly, the Montgomery Asberg Depression Rating Scale (MADRS) showed a notable decrease of -16.6 at four hours and -22.9 at Day 10.

Additionally, suicidal ideation decreased by 80%, with the percentage of individuals reporting suicidal thoughts dropping from 12.5% at baseline to 2.6% by Day 10.

SPN-820 was well-tolerated, exhibiting a low discontinuation rate of 2.5% due to adverse events (AEs). The most commonly reported adverse events related to the drug included headache, nausea, somnolence, and dizziness, while other adverse events observed included cognitive disorder, dry mouth, fatigue, nasal decongestion, and oral paresthesia.