The results support “SP-26’s potential as a safe, well-tolerated and long-acting treatment for fibromyalgia.”
A preclinical study evaluating SP-26, Silo Pharma’s extended-release ketamine implant, yielded positive results, the company said.
The results support “SP-26’s potential as a safe, well-tolerated and long-acting treatment for fibromyalgia,” Silo asserted in a news release.
All study endpoints were met, including survival, clinical observations, body-weight stability, neurological assessments and histopathological evaluation, according to the company.
“We believe these results support the advancement of SP-26 as a next-generation therapeutic for fibromyalgia, combining the proven efficacy of ketamine with the safety and convenience of extended-release delivery,” Silo Pharma CEO Eric Weisblum said.
The study, which was conducted in minipigs, evaluated the pharmacokinetics, safety and local tolerability of SP-26 formulations when administered subcutaneously.
“SP-26 implants are designed to deliver ketamine at a controlled rate, avoiding the dissociative effects associated with IV bolus injection and providing a viable alternative to highly addictive opioid treatments,” the company explained in a news release.
Silo provided these study highlights:
- Safety profile – No implant-related adverse events were observed. Animals maintained a healthy weight, normal neurological behavior and full survival to study conclusion.
- Sustained drug release – Ketamine was steadily released post-implantation, with measurable systemic exposure achieved across all dose levels. Peak drug levels were reached within one hour in most subjects, with sustained plasma concentrations observed for up to 22 days.
- Minimal tissue reaction – Both formulations elicited only minimal to mild chronic inflammation at the implant sites, with no dose-dependent or formulation-specific differences.
“SP-26 has been designed to offer a new approach to pain management by providing sustained, sub-psychedelic levels of ketamine in an abuse-deterrent format,” Weisblum said. “Preclinical SP-26 research overall has focused on ensuring that the safety profile of SP-26 aligns with FDA requirements for potential at-home therapeutic designation. If approved, SP-26 could become the first at-home injectable ketamine-based therapeutic.”