Silo Pharma Announces Positive Initial Pharmacokinetic, Safety & Tolerability Study of SP-26 for Chronic Pain and Fibromyalgia
Silo Pharma, Inc. recently announced a positive update from an ongoing study evaluating the pharmacokinetics, safety and tolerability of its novel SP-26 ketamine extended-release rods when implanted subcutaneously. The SP-26 implant is a novel self-administered, non-opioid therapeutic intended for the treatment of chronic pain and fibromyalgia.
The launch of our non-GLP study in December 2024 marked the first small animal testing of SP-26, a key preclinical milestone. Implantation (dosing) was completed in the first week of January 2025 and no animals experienced serious side effects or discomfort. Absorption, distribution, metabolism, and excretion (ADME) testing is nearing completion and final safety, and pharmacokinetic reports are expected in March 2025.
“We are encouraged by the early initial data from the SP-26 animal study, with no abnormal clinical observations reported so far,” said Eric Weisblum, CEO of Silo. “We believe that a successful final outcome would provide clear, actionable data for validating the advancing of SP-26 as a potential treatment for chronic pain.”
SP-26 is a ketamine-based injectable dissolvable polymer implant for the treatment of chronic pain and fibromyalgia. The subcutaneous implant is being designed to safely regulate dosage and time release of the pain-relieving treatment. If clinically successful, SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval.
Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company focused on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. The company’s portfolio includes innovative programs such as SPC-15 for PTSD, 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. silopharma.com.
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