Seelos Therapeutics said that the first part of a Phase 2 study of its SLS-002 intranasal racemic ketamine for the treatment of acute suicidal ideation and behavior in patients with major depressive disorder (MDD) demonstrated significant reductions in suicidality and depression. Seelos had announced the initiation of the study in January 2021. The open label portion of the study enrolled 17 patients who were hospitalized due to a significant risk of suicide and a history of at least one suicide attempt.
The FDA granted SLS-002 Fast Track designation for the treatment of acute suicidal ideation in MDD in November 2019. In April 2021, the company announced that it had signed a deal with Aptar Pharma for use of Aptar’s Bidose Liquid System (BDS) for SLS-002.
Seelos Chairman and CEO Raj Mehra commented, “Rapid and clinically meaningful efficacy both as an anti-depressive and anti-suicidal therapeutic after a single dose could make SLS-002 an ideal therapy for this large unmet need of acute suicidality in major depression. These are trying times in our battle against the suicide epidemic, which has been exacerbated by the COVID-19 global pandemic, and SLS-002 could create a paradigm shift allowing better treatment for these patients.”
Chief Medical Officer Tim Whitaker said, “As a researcher, and as a psychiatrist and former clinician who previously treated many patients with MDD and imminent risk of suicide, I am very impressed by these data. We are currently training additional trial sites and look forward to initiating Part 2 of our study, which will be double-blind and placebo-controlled.”
Read the Seelos Therapeutics press release.
