Silo Pharma Advances Regulatory Path for PTSD Treatment SPC-15
LOS ANGELES- Silo Pharma, Inc. a developmental stage biopharmaceutical company, has submitted a proposal for FDA approval of its PTSD treatment, SPC-15, through the 505(b)(2) regulatory pathway. This pathway is designed to shorten clinical timelines and reduce development costs. The company recently completed a pre-Investigational New Drug (pre-IND) meeting with the FDA, receiving feedback to support opening an IND for first-in-human trials of SPC-15, an intranasal treatment for PTSD and stress-induced anxiety.
CEO Eric Weisblum stated that the company now has a clear path to clinical development, with plans to bring SPC-15 to market following FDA approval. Silo is currently conducting pharmacokinetic and pharmacodynamic studies as part of its ongoing preparations. With an exclusive license from Columbia University, Silo aims to further develop, manufacture, and commercialize SPC-15 globally.
Silo Pharma’s pipeline includes treatments for PTSD, chronic pain, and central nervous system disorders, with a focus on novel drug formulations and delivery systems, including psychedelics.