Seelos Therapeutics announced that the first patients have been dosed in a Phase 2 study of its SLS-002 intranasal racemic ketamine for the treatment of acute suicidal ideation and behavior in patients with major depressive disorder. In November 2019, Seelos announced that it had been granted Fast Track designation for SLS-002 for this indication, and in January 2020, the company said that it had scheduled a Type C meeting with the FDA regarding a Phase 3 trial.
The first part of the study is expected to enroll 16 patients who will receive 90mg of SLS-002 twice a week for two weeks plus standard of care; the second part of the study is expected to enroll 120 patients who will get either 90 mg of SLS-002 or placebo on the same schedule. According to the Seelos web site, SLS-002 is delivered via the Aptar Pharma Bidose device.
Seelos Therapeutics Chairman and CEO Raj Mehra said, “The dosing of the first patients in our study could not come at a more crucial time as there still remains a high unmet need for a therapy to address the symptoms of suicidality. We will continue to train and add trial sites and look forward to sharing the open-label data from the first 16 patients once dosing, safety follow up, and data analysis have been completed.”
Read the Seelos Therapeutics press release.
