Silo Pharma’s SP-26 Ketamine Implant Meets All Endpoints in Preclinical Fibromyalgia Study

LOS ANGELES- Silo Pharma Inc. a developmental-stage biopharmaceutical company, announced that its investigational ketamine implant, SP-26, met all primary endpoints in a preclinical study targeting fibromyalgia. The study, conducted in minipigs, assessed the implant’s safety, tolerability, and pharmacokinetics.

Study Findings

The SP-26 implant demonstrated a favorable safety profile, with no implant-related adverse events observed. Animals maintained stable body weight and normal neurological behavior throughout the study period. The implant achieved sustained systemic ketamine exposure for up to 22 days, with peak plasma concentrations reached within one hour post-implantation. Minimal to mild chronic inflammation was noted at the implant sites, with no dose-dependent differences observed.

SP-26 is a subcutaneous, extended-release ketamine implant designed to deliver controlled, sub-psychedelic levels of ketamine over an extended period. The implant aims to provide an alternative to traditional opioid-based therapies for chronic pain conditions such as fibromyalgia. Silo Pharma intends to pursue the FDA’s 505(b)(2) regulatory pathway for SP-26, which allows for a streamlined approval process by leveraging existing data on ketamine.

Following the positive preclinical results, Silo Pharma plans to advance SP-26 into clinical development. The company aims to position SP-26 as a potential at-home injectable ketamine-based therapeutic for fibromyalgia and other chronic pain conditions.