Seelos Therapeutics said that it has scheduled a Type C meeting with the FDA for March 2020 regarding a Phase 3 trial of its SLS-002 intranasal racemic ketamine for the treatment of acute suicidal ideation and behavior (ASIB) in patients with major depressive disorder (MDD). The FDA granted Fast Track designation to SLS-002 in November 2019.
According to the company, data from Phase 1 PK/PD and drug-drug interaction studies is expected during the first quarter of this year.
Seelos Chairman and CEO Raj Mehra said, “Continued communication with FDA is essential for the development of SLS-002 in this high unmet need of ASIB in MDD. We are diligently striving to advance the program forward as we share the Phase 1 data from the ongoing studies throughout the first quarter.”
Read the Seelos Therapeutics press release.
