New Treatment for Acute Suicidal Ideation and Behavior

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The first patient has been dosed in the second part of Seelos Therapeutics’ registrational study of their formulation of intranasal racemic ketamine (SLS-002) for acute suicidal ideation and behavior (ASIB) in patients with major depressive disorder (MDD).

“There is a significant unmet need within the MDD market for pharmacotherapies that can demonstrate rapid antidepressant effects, in particular for patients with severe MDD requiring hospitalization including those with ASIB. In part 1 of the study, SLS-002 showed significant improvement in depressive symptoms at 24 hours compared to placebo,” said Philippa Salter, Neurology Analyst at GlobalData.¹

If approved, SLS-002 would become the second product approved specifically for ASIB. The first product, Johnson & Johnson’s rapid-acting esketamine (Spravato), was approved for moderate-to-severe MDD patients with ASIB in 2020. Due to risk of sedation and disassociation, Spravato is only available through a restricted program.

“Although Spravato was a breakthrough treatment for ASIB, its high cost of therapy, and requirement for 2 hours of patient observation after administration will also limit its uptake,” Salter continued. “As a related compound, and with the same intranasal route of administration, it is possible that SLS-002 will face similar issues to Spravato. However, in a small, randomized trial intranasal ketamine caused minimal dissociative effects, which, if replicated in larger trials, would give SLS-002 an advantage over Spravato.”¹

Several fast-acting antidepressants are looking to enter the market, including the following late-stage products: Sage Therapeutics/Biogen’s zuranolone (SAGE-217); Axsome Therapeutics’ bupropion and dextromethorphan (AXS-05); and Relmada Therapeutics’ REL-1017. While these products are not specifically in development for ASIB, if they demonstrate strong efficacy for MDD, a label expansion could be sought in the future.

Reference

1. GlobalData. Seelos Therapeutics’ SLS-002 could be a strong competitior to Spravato for treatment of suicidal behavior, says GlobalData. News release. July 13, 2021. Accessed July 16, 2021. https://www.globaldata.com/seelos-therapeutics-sls-002-strong-competitior-spravato-treatment-suicidal-behavior-says-globaldata/