Silo Pharma is preparing 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 – SPC-26 – for the treatment of fibromyalgia.
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.
The condition affects an estimated 4 million American adults, which equates to around 2 per cent of the adult population. There is no cure for the condition, and current treatments for fibromyalgia are limited to pain killers, talking therapies and exercise, highlighting the need for new and innovative symptom management.
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.
To date, 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.
Silo Pharma CEO Eric Weisblum, commented: “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.”
Premier Consulting will assist Silo Pharma 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.
