Novel Psychedelic Compound For The Treatment Of Fibromyalgia Begins Dosing In Safety Trial

Developmental-stage psychedelics biotech company Silo Pharma Inc. SILO has begun dosing in its IND-enabling study of proprietary time-released, topical formulation of ketamine SP-26 designed to treat fibromyalgia. 

This safety evaluation trial will be conducted by Experimur, a Frontage Company, and intends to evaluate the tolerability of SP-26 to establish a maximum dose in the treatment of this chronic medical condition causing widespread musculoskeletal pain as well as memory issues, sleep difficulties and fatigue.

Silo Pharma’s CEO Eric Weisblum stated the company is excited about the milestone achieved together with partner South Carolina-based Zylö Therapeutics. 

“Together we have developed a delivery method for a new ketamine formulation that has shown in pre-clinical studies to hold and distribute the drug in a time-released fashion and reduce neuropathic nerve pain. This IND-enabling study coupled with our existing data brings us another step closer to testing in human patients,” Weisblum explained.

Further, Silo Pharma and a regulatory partner are advancing preparations to submit a pre-Investigational New Drug (IND) package submission for novel drug SP-26 to the FDA through the 505(b)(2) regulatory pathway -that is, an application that includes one or more clinical or nonclinical studies that are necessary for approval but were not yet conducted by the applicant and for which the applicant does not have right of reference.

According to Fortune Business Insights, the fibromyalgia treatments market was valued at $764 million in 2020 and will be worth $1.4 billion in 2027 with a Compound Annual Growth Rate (CAGR) of 9.2% over the next five years.

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