The Food and Drug Administration (FDA) has granted Fast Track designation to an investigational intranasal formulation of racemic ketamine for the potential treatment of acute suicidal ideation and behavior in patients with major depressive disorder.
The ketamine program, SLS-002, is being developed by Seelos Therapeutics. A phase 1 study evaluating the pharmacokinetics, pharmacodynamics, and drug-drug interactions of SLS-002 is expected in the first quarter of 2020. The study is expected to include 48 healthy volunteers randomized to receive a combination of SLS-002 and either venlafaxine extended-release or sertraline.
Fast Track designation allows for more frequent meetings and discussions with the FDA and eligibility for Priority Review if the right criteria are met.
“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,” said Seelos CEO, Raj Mehra, PhD.
Earlier this year, the Agency approved esketamine nasal spray (Spravato; Janssen) to treat treatment-resistant depression, in conjunction with an oral antidepressant. Additionally, in recommendations recently published for reducing suicide among veterans, it was found that ketamine reduced suicidal ideation compared with placebo or midazolam.
For more information visit seelostherapeutics.com.