Seelos Therapeutics has completed enrollment in its registration-directed study of SLS-002, an intranasal racemic ketamine for treating acute suicidal ideation and behavior (ASIB) in adults with major depressive disorder (MDD). The two-part clinical trial includes an open-label cohort followed by a randomized, double-blind, placebo-controlled study. Seelos aims to address the unmet need for therapy to treat suicidality in the US with SLS-002. Top-line data from this study is expected in Q3 2023. There is currently no FDA-approved treatment for ASIB in MDD.
In 2021 there were 48,183 suicides in the US and unfortunately, the medical community still lacks an FDA-approved therapeutic to treat the symptoms of suicidality. Suicidal patients who present suicidal ideation and behavior symptoms at an emergency department can be held there for several days while awaiting an inpatient psychiatric bed. Currently, there is a shortage of over 120k inpatient psychiatric beds.
SLS-002 was originally derived from a Javelin Pharmaceuticals/Hospira program