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Silo Pharma’s SPC-15 Intranasal PTSD Program: Device Robustness Study and Regulatory Pathway
Silo Pharma announced a robustness study by Resyca for its microchip-based Soft-Mist Nasal Spray system delivering SPC-15, a PTSD prophylactic, to support a planned FDA Type C meeting and Phase 1 trial design.
The study evaluates device performance consistency and the stability of SPC-15 and placebo formulations over a 30-day period, supporting the combination product's development.
The study is expected to support Silo’s planned FDA Type C meeting request, where it will seek regulatory guidance on its IND strategy and Phase 1 clinical trial design.
The study is being conducted by Silo’s drug-device development partner, Resyca.
Silo aligned with the FDA to pursue the streamlined 505(b)(2) regulatory pathway for SPC-15 following a pre-IND meeting.
The portfolio includes SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer’s disease and multiple sclerosis.
Silo’s research is conducted in collaboration with leading universities and laboratories.
The latest news and updates are available in the company’s newsroom at https://nnw.fm/SILO.