Supernus announces data from SPN-820 study

Supernus (SUPN) Pharmaceuticals announced 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 three 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. Clinically meaningful improvement of -6.1 at two hours and -9.6 at Day 10 on the Hamilton Depression Rating Scale-6 Items, or HAM-D6, total score. Clinically meaningful improvement of -16.6 at four hours and -22.9 at Day 10 on the Montgomery Asberg Depression Rating Scale, or MADRS, total score. Suicidal ideation decreased by 80%. SPN-820 was well-tolerated with few adverse events, or AEs, and had acceptable tolerability with a discontinuation rate of 2.5% due to AEs. Most common AEs related to the drug included headache, nausea, somnolence, and dizziness. Additional AEs such as cognitive disorder, dry mouth, fatigue, nasal decongestion, and paresthesia oral were observed.