Update shared on23 Apr 2025
SP-26 Achieves Major Preclinical Milestone, Paving the Way for First At-Home Ketamine Therapy for Fibromyalgia.
Silo Pharma has just reported encouraging preclinical results for SP-26, its innovative ketamine-based implant designed for chronic pain, including fibromyalgia. The study showed that SP-26 safely delivers ketamine in a slow, steady release over several weeks—without the side effects seen in IV ketamine and without the risks tied to opioids.
The extended-release implant met all safety and tolerability benchmarks, with no significant side effects and minimal tissue reaction in animal models. Importantly, it maintained stable ketamine levels in the body for up to 22 days, demonstrating its potential for long-lasting, self-administered pain relief.
These findings are a key step toward SP-26 entering clinical trials and reinforce its potential to become the first at-home injectable ketamine treatment for fibromyalgia—a $4B+ market with limited non-opioid options today.
With this progress, SP-26 is on track for FDA submission under the accelerated 505(b)(2) pathway, opening the door to faster development and commercialization. For investors familiar with Silo’s strategy, this milestone strengthens confidence in the company's broader CNS pipeline and commercial potential.
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