Silo Pharma (NASDAQ: SILO), a developmental-stage biopharmaceutical company focused on developing novel formulations and drug-delivery systems for traditional therapeutics and psychedelic treatments, has completed a pre-Investigational New Drug (“IND”) meeting with the U.S. Food and Drug Administration (“FDA”). The meeting focused on the company’s development plan for SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (“PTSD”) and stress-induced anxiety disorder. According to the announcement, the meeting was conducted through written responses provided by the FDA’s Division of Regulatory Operations for Neuroscience (“DRON”) — Psychiatry Group, which included submitting a proposal for FDA 505(b)(2) regulatory pathway for SPC-15 approval.
“The FDA provided helpful written responses on our development plan for SPC-15,” said Silo Pharma CEO Eric Weisblum in the press release. “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.”
To view the full press release, visit https://ibn.fm/asD2Q
About Silo Pharma Inc.
Silo Pharma is a developmental-stage biopharmaceutical company developing novel therapeutics that address underserved conditions including stress-induced psychiatric disorders, chronic pain conditions and central nervous system (“CNS”) diseases. Silo focuses on developing traditional therapies and psychedelic treatments in novel formulations and drug-delivery systems. The company’s lead program, SPC-15, is an intranasal treatment targeting post-traumatic stress disorder (“PTSD”) and stress-induced anxiety disorders. SP-26 is a time-release, ketamine-loaded implant for fibromyalgia and chronic pain relief. Silo’s two preclinical programs are SPC-14, an intranasal compound for the treatment of Alzheimer’s disease, and SPU-16, a CNS-homing peptide targeting multiple sclerosis (“MS”). Silo’s research and development programs are conducted through collaborations with universities and independent laboratories. For more information about the company, visit www.SiloPharma.com.
NOTE TO INVESTORS: The latest news and updates relating to SILO are available in the company’s newsroom at https://ibn.fm/SILO
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