Core Viewpoint - Silo Pharma, Inc. announced positive preclinical results for SP-26, an extended-release ketamine implant, indicating its potential as a safe and effective treatment for fibromyalgia [1][2]. Study Results - All study endpoints were met, including survival, clinical observations, body weight stability, neurological assessments, and histopathological evaluation [2]. - No implant-related adverse events were observed, with animals maintaining a healthy weight and normal neurological behavior throughout the study [3]. - Ketamine was steadily released post-implantation, achieving peak drug levels within 1 hour and sustaining plasma concentrations for up to 22 days [3]. Safety and Tolerability - Both SP-26 formulations elicited only minimal to mild chronic inflammation at the implant sites, with no significant differences based on dose or formulation [4]. - The design of SP-26 aims to provide sustained, sub-psychedelic levels of ketamine in an abuse-deterrent format, aligning with FDA safety requirements for potential at-home therapeutic designation [5]. Product Overview - SP-26 is a ketamine-based injectable dissolvable polymer implant intended for chronic pain and fibromyalgia treatment, designed to regulate dosage and time release safely [5]. - If clinically successful, SP-26 could qualify for the FDA's streamlined 505(b)(2) regulatory pathway for drug approval [5]. Company Background - Silo Pharma Inc. focuses on addressing underserved conditions, including chronic pain and psychiatric disorders, with a portfolio that includes programs for PTSD and preclinical assets targeting Alzheimer's disease and multiple sclerosis [6].
Silo Pharma's SP-26 Ketamine Implant Meets All Endpoints in Fibromyalgia Study