Silo Pharma announced that it has received responses from the FDA following a pre-IND meeting regarding SPC-15 soft mist intranasal ketamine for post-traumatic stress disorder (PTSD) and stress-induced anxiety disorder. Silo is planning to take advantage of the 505(b)(2) pathway for SPC-15, which it has licensed from Columbia University.
In November 2023, Silo announced that it had licensed Medspray’s soft mist technology for delivery of SPC-15. The company notes that GLP-compliant PK and PD studies to support an IND are underway and says that “Pre-clinical data to date indicate that SPC-15’s optimized patient safety and therapeutic delivery has additive benefits for combating stress-induced pathophysiology, both at the behavioral and neural levels.”
Silo CEO Eric Weisblum commented, “The FDA provided helpful written responses on our development plan for SPC-15. We now have a clear path for advancing our development of SPC-15 into the clinic for in-human trials which will hopefully lead to FDA approval and ultimately allow us to commercialize our patented, cutting-edge intranasal treatment, to the PTSD treatment market.”
Read the Silo Pharma press release.
