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Saturday, Dec 3, 2022
Mugglehead Magazine
Alternative investment news based in Vancouver, B.C.


Silo Pharma prepares pre-IND package for FDA on novel ketamine formulation

Company will collaborate with Premier Consulting as regulatory partner and utilize Zylö Therapeutics Z-Pod technology

Silo Pharma and Premier Consulting prepare pre-IND package for FDA on novel ketamine formulation
Photo via Psilo Pharma.

Silo Pharma, Inc. (Nasdaq: SILO) has now begun working on a new ketamine drug designed to treat fibromyalgia.

On Monday, the biopharmaceutical company announced that it had started collaborating with Premier Consulting as a regulatory partner to assist with preparing a pre-investigational new drug (IND) package and meeting application with the United States Food and Drug Administration (FDA) for a new topical variety of ketamine known as SPC-26.

The new drug is intended to treat fibromyalgia, a chronic condition causing widespread musculoskeletal pain accompanied by memory issues, sleep problems and fatigue.

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Premier Consulting will be helping Silo with the development of its “non-clinical, clinical, clinical pharmacology and biopharmaceutics strategy and program” that will be put forth to the FDA. Psilo also says that the pre-IND meeting request for cooperative conversation with the FDA will be made with the expectation of the filing of 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 Eric Weisblum, CEO of Silo Pharma.

“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.”

The 505(b)(2) section of the Federal Food, Drug, and Cosmetic Act deals with these varieties of drug applications to the FDA.

The company will also be collaborating with Zylö Therapeutics, Inc., a biotech company headquartered in South Carolina. Silo will be pursuing the development of its new ketamine formulation using Zylö’s Z-pod technology and says that pre-clinical studies have demonstrated that the Z-pod can “hold and distribute” ketamine in a time-release fashion.

Silo cites that according to Fortune Business Insights, the market for fibromyalgia treatments was valued at US$764.1 million in 2020 and will be worth US$1.4 billion in 2027 with a compound annual growth rate (CAGR) of 9.2 per cent over the next five years.


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