A Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with MDD at Imminent Risk of Suicide.

No approved therapy exists for suicidal ideation and behavior (SI/B) in Major Depressive Disorder (MDD), though ketamine shows rapid antidepressant effects. While FDA-approved esketamine reduced suicidality indicators, its effects did not significantly surpass placebo. Racemic ketamine, a mixture of esketamine and arketamine, may better alleviate SI/B. In an open-label study, 17 hospitalized MDD patients with acute SI/B received intranasal racemic ketamine (SLS-002). Treatment significantly reduced depression and suicidality scores on four clinical scales, including the Montgomery-Åsberg Depression Rating Scale and Sheehan-Suicidality Tracking Scale. SLS-002 was well tolerated with an acceptable safety profile, supporting continued development.

Study at a glance

Abstract

Despite the prevalence of Major Depressive Disorder (MDD) and the propensity of affected individuals to eventually die by suicide, there is no therapeutic approved specifically for suicidal ideation and behavior (SI/B) in MDD. The NMDA receptor antagonist ketamine has been investigated for the treatment of depression and shown to have a rapid effect on symptoms. Spravato® (esketamine) is approved by the FDA for use in treatment-resistant depression and Major Depressive Episodes with Suicidal Ideation based on studies conducted in adults also taking standard antidepressants. While esketamine was associated with a large reduction in suicidality indicators, the effects did not significantly exceed those associated with placebo. Racemic ketamine, a mixture of both esketamine and arketamine, may hold greater potential for the rapid alleviation of SI/B. SLS-002 was developed as an investigational intranasal racemic ketamine for the treatment of SI/B in individuals with MDD. In part one of a two-part clinical trial, the safety, tolerability, and potential effectiveness of SLS-002 were evaluated in an open label study of 17 patients with MDD hospitalized with acute SI/B. Treatment with SLS-002 was associated with a significant reduction in depression and suicidality indicators on four clinical scales: the Montgomery-Åsberg Depression Rating Scale, the Sheehan-Suicidality Tracking Scale, and the Clinical and Patient Global Impression Scales for SI/B. SLS-002 was well tolerated with an acceptable safety profile. The results of this open label study support the continued development of SLS-002. The randomized double-blind placebo-controlled part two of this trial was recently completed.