According to Seelos Therapeutics, the FDA has granted Fast Track designation to its SLS-002 intranasal racemic ketamine for the treatment of acute suicidal ideation and behavior in patients with major depressive disorder. The company also said that it expects data from a Phase 1 study of SLS-002 in early 2020.
In October 2019, Seelos announced that it had amended its agreement with Vyera Pharmaceuticals (formerly Turing Pharmaceuticals) regarding development of SLS-002. Initiation of a Phase 1 study of SLS-002 (formerly TUR-002) was announced by Turing Pharmaceuticals in January 2016.
Seelos Chairman and CEO Raj Mehra said, “The decision by the FDA to grant Fast Track designation to SLS-002 underscores the significant unmet medical need for patients with acute suicidal ideation and behavior in major depressive disorder. We will be working diligently in close collaboration with the FDA to finalize the protocol for the proof of concept study and future clinical development.”
Head of R&D Tim Whitaker commented, “While I was a psychiatrist working in an academic teaching hospital, I saw and treated many of these patients. The limited medical treatment options have been a source of great frustration to patients, their families, and their healthcare practitioners. SLS-002 has promise to help address this critical unmet need. We are encouraged by the FDA’s Fast Track designation as this moves the program forward in a meaningful way.”
Read the Seelos Therapeutics press release.
