Silo Pharma's SPC-15 for PTSD Reaches Key Safety Milestone, Clearing Path for Faster Clinical Trials via 505(b)(2) Pathway

SPC-15 Safety Study Results: Silo Pharma announced positive results from a 7-day safety study of its intranasal spray formulation SPC-15, confirming it meets FDA safety standards for clinical trials.

Intranasal vs. Oral Administration: The preclinical study demonstrated that the intranasal SPC-15 showed comparable systemic exposure and safety to oral administration, supporting its potential as a targeted therapeutic for PTSD.

Regulatory Strategy: Silo plans to utilize a 505(b)(2) regulatory strategy to streamline the FDA approval process for SPC-15, leveraging existing safety and efficacy data from approved drugs.

Market Growth Potential: The PTSD market is projected to grow from $1.8 billion in 2024 to $3.2 billion by 2034, driven by increased focus on mental health and personalized treatment solutions.