Seelos receives FDA feedback on endpoints of Phase 2 SLS-002 trial in MDD

Seelos Therapeutics received minutes from its End of Phase II Meeting with the FDA. In the meeting minutes, the FDA agreed that the primary endpoint in a Phase III trial could be the change from baseline in the Montgomery-Asberg Depression Rating Scale total score at Day 16, rather than the 24-hour timepoint that was selected in the Phase II SLS-002-201 study. The key secondary endpoint could be the change from baseline at 24 hours on the suicidality scale. This agreement with the FDA gives Seelos further confidence for its Phase III development of SLS-002 as data in the Phase II study showed clinically significant treatment differences from placebo on both the Day 16 MADRS and the 24-hour Sheehan- Suicidality Tracking Scale.