Seelos Therapeutics, Inc. announced the close of enrollment of its registration directed study of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Behavior (ASIB) in adults with Major Depressive Disorder (MDD). In 2021 there were 48,183 suicides in the U.S. and unfortunately, the medical community still lacks an FDA approved therapeutic to treat the symptoms of suicidality. According to the Centers for Disease Control and Prevention (CDC), in 2020, suicides and non-fatal self-harm cost the U.S. over $500 billion in medical and work-loss costs, value of statistical life, and quality of life costs.

Suicidal patients who present suicidal ideation and behavior symptoms at an Emergency Department and can be held in the Emergency Department for several days while awaiting an inpatient psychiatric bed. Currently in the U.S., there is a shortage of over 120,000 inpatient psychiatric beds and the average length of hospitalization for a suicidal patient is 10 days. Seelos' study is a multicenter, two-part clinical trial, comprised of the Part 1 open-label cohort, for which data was released in May 2021, followed by Part 2, a randomized, double-blind, placebo-controlled study.

The purpose of the study is to evaluate the efficacy, safety, and tolerability of repeat doses of SLS-002 (Intranasal racemic ketamamine) in addition to clinical standard of care on the symptoms of MDD and suicidality in adults who are assessed to be at an imminent risk of suicide. About SLS-002 SLS-002 is intranasal racemic ket examine with two investigational new drug applications for the treatment of Acute Suicidal Ideation & Behavior in Major Depressive Disorder and in Post-Traumatic Stress Disorder. SLS-002 was originally derived from a Javelin Pharmaceuticals Inc./Hospira Inc. program with 16 clinical studies involving approximately 500 subjects.

Seelos looks to address an unmet need for a therapy to treat suicidality in the U.S. with SLS-002.