Seelos Therapeutics said that it has initiated a Phase 1 study comparing PK profiles of SLS-002 intranasal racemic ketamine in Japanese and non-Asian adults. In May 2021, the company announced positive Phase 2 results for SLS-002 for the treatment of acute suicidal ideation and behavior in patients with major depressive disorder. The intranasal ketamine is delivered via Aptar Pharma’s Bidose Liquid System (BDS).
According to Seelos, the company designed the new study in consultation with the FDA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and that the goal is inclusion of Japanese subjects in a future study of the nasal spray for the treatment of major depressive disorder. In September 2020, Seelos announced that it had received a Japanese patent covering the use of SLS-002 for anxiety caused by phobias.
Seelos Chairman and CEO Raj Mehra commented, “This ethnobridging study is an important first step as we begin evaluating the potential for SLS-002 in patients globally. Our market research suggests a high unmet global need for a therapy with both antidepressant and anti-suicidal effects.”
Read the Seelos Therapeutics press release.
