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Silo Pharma to utilize Zylö Therapeutics Z-Pod technology to prepare pre-IND package for FDA


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.

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.

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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Tamia Sumpter

Tamia is a driven senior undergraduate Bioengineering student currently enrolled at Clemson University. With a strong foundation in her field, she has honed her skills through hands-on experience in research and development at Eli Lilly & Company. During her time in the ADME department, Tamia contributed significantly by working on siRNAs and their applications in finding In Vitro-In Vivo Correlation (IVIVC). Looking ahead, Tamia has set her sights on a promising career in law. She aspires to specialize in Intellectual Property Law, with a particular focus on serving as in-house counsel for leading medical device or pharmaceutical companies. Her enthusiasm for this role is palpable as she prepares to embark on her legal journey! She is also a proud member of the Omicron Phi chapter of Delta Sigma Theta Sorority, Inc., PEER Mentor for Clemson PEER/WiSE, and currently serves as the President of Clemson Bioengineering Organization (CBO). With her unique blend of scientific knowledge and legal interests, Tamia is poised to make a meaningful impact in the healthcare and life sciences industries.