Supernus announces data from SPN-820 study

Supernus (SUPN) announced data in a poster presentation at Psych Congress 2024 with new data from its exploratory open-label Phase 2a clinical study of SPN-820 in adults with major depressive disorder, or MDD. The study examined the safety and tolerability of 2400 mg of SPN-820 given once every three days as an adjunctive treatment to the current baseline antidepressant therapy and assessed the rapid onset of improvement in depressive symptoms. The study included 40 enrolled subjects, of which 38 completed the 10-day treatment period. In the Phase 2a study, SPN-820 demonstrated a 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, as well as a clinically meaningful improvement of -16.6 at four hours and -22.9 at Day 10 on the Montgomery Asberg Depression Rating Scale, or MADRS. New data from the Phase 2a study presented at Psych Congress 2024 demonstrate a rapid MADRS response rate and remission, reaching 50% and 35% of participants, respectively, at four hours, with additional improvement to 84.2% and 63.2% by Day 10. Suicidal ideation decreased by 80%. SPN-820 was well-tolerated with few adverse events, or AEs, and had acceptable tolerability with a low discontinuation rate due to AEs. Most common AEs related to the drug were mild to moderate and included headache, nausea, somnolence, and dizziness. Additional AEs such as cognitive disorder, dry mouth, fatigue, nasal decongestion, and paresthesia oral were observed and considered mild to moderate. There were no severe AEs and no serious AEs reported.