Silo Pharma Initiates FDA Pre-Investigational New Drug (IND) Package for Time-Released Ketamine Technology
Company intends to pursue 505(b)(2) regulatory pathway for novel topical formulation of ketamine
ENGLEWOOD CLIFFS, NJ, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today announced that it is working with Premier Consulting as its regulatory partner to assist with the preparation of a pre-Investigational New Drug (IND) package and meeting request with the United States Food and Drug Administration (FDA) for a novel topical formulation of ketamine, designated as SPC-26, for the treatment of fibromyalgia.
Premier Consulting will assist the Company with the development of its nonclinical, clinical, clinical pharmacology, and biopharmaceutics strategy and program to be proposed to the FDA. The submission of a pre-IND meeting request for collaborative discussions with the FDA will be made in anticipation of the filing a clinical IND package.
“We are confident that our highly constructive pre-clinical work on SP-26 will offer strong support for our pre-IND package as we seek to advance our time-released ketamine delivery system into the clinic,” said CEO Eric Weisblum. “We intend to pursue the 505(b)(2) regulatory pathway and have engaged Premier Consulting as a true strategic partner to pave the way for productive discussions and alignment with the FDA.”
In collaboration with joint venture partner Zylö Therapeutics, Inc. (ZTI), Silo Pharma is pursuing the clinical development of ketamine using ZTI’s Z-pod™ technology. Pre-clinical studies have shown that the Z-pod can hold and distribute ketamine in a time-released manner, and the Company has determined to pursue fibromyalgia as an initial indication.
Fibromyalgia is a chronic condition causing pain to the connective tissues through the body including muscles, ligaments, and tendons. Musculoskeletal pain is often accompanied by sleep difficulties, fatigue, mood disorders, and problems with memory and concentration. Fibromyalgia affects about 4 million American adults, or about 2% of the adult population. According to Fortune Business Insights1, the fibromyalgia treatment market is projected to grow from $764.1 million in 2020 to $1,414.4 million in 2027, at a CAGR of 9.2% in the 2020-2027 period.
About Silo Pharma
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, Parkinson’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
Forward-Looking Statements
All statements other than statements of historical fact in this announcement are forward-looking statements, including but not limited to, the Company's proposed Offering. These forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations and projections about future events and financial trends that the Company believes may affect its financial condition, results of operations, business strategy and financial needs, including the expectation that the Offering will be successfully completed. Investors can identify these forward-looking statements by words or phrases such as "may," "will," "expect," "anticipate," "aim," "estimate," "intend," "plan," "believe," "potential," "continue," "is/are likely to" or other similar expressions. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in the Company's registration statement and in its other filings with the SEC.
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1 Fibromyalgia Treatment Market Size, Share and Trends, 2027 - Sept. 28, 2022
