Seelos therapeutics announces positive topline data from the open-label study of sls-002 (intranasal racemic ketamine), demonstrating a significant treatment effect and a well tolerated safety profile for acute suicidal ideation and behavior in patients with major depressive disorder
New york, may 17, 2021 /prnewswire/ -- seelos therapeutics, inc. (nasdaq: seel), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system (cns) disorders and rare diseases, today announced positive data from part 1, the open-label cohort, of its potentially registrational proof-of-concept study of sls-002 (intranasal racemic ketamine) demonstrating a significant treatment effect and a well-tolerated safety profile for acute suicidal ideation and behavior (asib) in patients with major depressive disorder (mdd). "rapid and clinically meaningful efficacy both as an anti-depressive and anti-suicidal therapeutic after a single dose" this study enrolled 17 subjects diagnosed with mdd requiring psychiatric hospitalization due to significant risk of suicide with a baseline score of ≥ 28 points on the montgomery-Åsberg depression rating scale (madrs), a score of 5 or 6 on madrs item-10, a score of ≥ 15 points on the sheehan-suicidality tracking scale (s-sts) total score and a history of previous suicide attempt(s), as confirmed on the columbia suicide severity rating scale (c-ssrs) with a history of at least one actual attempt, or if the attempt was interrupted or aborted, is judged to have been serious in intent.
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