Silo Pharma Initiates Toxicity Study of its Proprietary Ketamine Formulation for Treatment of Fibromyalgia
Silo Pharma, Inc. recently announced it has initiated a preclinical toxicity study of its novel time-released, dosage controlled formulation of ketamine, designated as SP-26, for the treatment of fibromyalgia.
Eric Weisblum, CEO of Silo Pharma, said “We are working closely with our joint venture partner Zylö Therapeutics in developing a topical sustained-released ketamine utilizing Z-pod technology. Preclinical studies have already shown that our joint developed delivery method and formulation can hold and distribute ketamine in a time-released manner. SP-26 reported positive results in reducing neuropathic nerve pain. This safety evaluation study will uncover maximum tolerated dosing data that will inform our future trials.”
In the safety evaluation study, the tolerability of the SP-26 compound will be determined in a mini pig study using an ascending (descending) dosing regimen. Data from the study is expected in the first quarter of 2023.
Silo Pharma recently announced that it is working with a regulatory partner to prepare an FDA Pre-Investigational New Drug (IND) package for SP-26. The Company intends to pursue a 505(b)(2) regulatory pathway for the drug candidate.
Silo Pharma. Inc. is a development-stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as PTSD, Alzheimer’s, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the healthcare industry. For more information, visit www.silopharma.com
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