Silo Pharma, Inc. (Nasdaq: SILO), 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 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. 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.”Eric Weisblum CEO
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.