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Silo Pharma Inc.’s (NASDAQ: SILO) Novel Ketamine Formulation Undergoing Safety Evaluation, Pursuing Regulatory Pathway
October 24, 2022

Silo Pharma Inc.’s (NASDAQ: SILO) Novel Ketamine Formulation Undergoing Safety Evaluation, Pursuing Regulatory Pathway

  • Ketamine used for decades in large doses for surgical anesthesia, low-dose treatments currently prescribed for pain relief, sedation, and treatment-resistant depression
  • Silo’s time-released ketamine formulation SP-26 currently undergoing safety evaluation, study to uncover maximum tolerated dosing data for future trials
  • SP-26 previously reported positive results in reducing neuropathic nerve pain
  • Silo preparing FDA Pre-Investigational New Drug (“IND”) package for SP-26, intends to pursue 505(b)(2) regulatory pathway

Ketamine was approved in the United States in 1970 and has been used extensively for surgical anesthesia. Since then, use of the drug in small doses has expanded considerably to treat pain and treatment-resistant depression (

Silo Pharma (NASDAQ: SILO), a developmental stage biopharmaceutical company focused on the use of traditional medicine and psychedelics as therapeutics, is currently developing ketamine treatments for fibromyalgia – a chronic disease that causes pain throughout the body. With no cure available, fibromyalgia can be a debilitating condition that extends beyond pain to cause extreme fatigue, anxiety, and memory issues.

Silo’s novel ketamine formulation, designated as SP-26, is currently undergoing a safety evaluation to treat fibromyalgia ( “We are working closely with our joint venture partner Zylö Therapeutics in developing a topical sustained released ketamine utilizing Z-pod(TM) technology,” said Eric Weisblum, CEO of Silo Pharma.

“Preclinical studies have already shown that our joint developed delivery method and formulation can hold and distribute ketamine in a time-released manner. SP-26 reported positive results in reducing neuropathic nerve pain. This safety evaluation study will uncover maximum tolerated dosing data that will inform our future trials.”

Silo’s cooperation with Zylö Therapeutics provides a distinct competitive advantage for the formulation through the use of Zylö’s Z-pod(R) delivery system that provides treatment benefits while reducing hallucinogenic effects ( With the ability to adapt to the characteristics of a specific compound, Z-pods(R) can be customized to target delivery, increase bioavailability, and improve stability. 

The company additionally announced collaboration with a regulatory partner to prepare an FDA Pre-Investigational New Drug (“IND”) package for SP-26 with the intention of pursuing a 505(b)(2) regulatory pathway for the drug candidate (

“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 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.”

Silo Pharma Inc. is fusing traditional therapeutics with psychedelic research to provide novel treatments for numerous indications, including post-traumatic stress disorder (“PTSD”), fibromyalgia, Alzheimer’s disease, and other rare neurological disorders. The company’s mission is to identify assets to license and fund research with leading universities for treatments the company believes will transform the healthcare industry and improve patient outcomes.

For more information, visit the company’s website at

NOTE TO INVESTORS: The latest news and updates relating to SILO are available in the company’s newsroom at

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