Silo Pharma Proceeds with Ketamine Implant for Chronic Pain

The firm is targeting the FDA’s 505(b)(2) pathway for a potentially expedited approval process.

Developmental-stage biopharmaceutical Silo Pharma, Inc. (Nasdaq: SILO) reported progress in the development of SP-26, a ketamine-loaded implant intended for home treatment of fibromyalgia and other chronic pain conditions.

The company, in partnership with Sever Pharma Solutions, is conducting analytical testing and pre-clinical trials to determine the drug release and stability of the implant. The stage is critical in assessing the implant’s potential effectiveness and safety, the company noted.

Eric Weisblum, CEO of Silo Pharma, reinforced the company’s intention to address the need for non-opioid pain relief treatments.

“Based on findings to date, we believe SP-26 has the potential to be the first at-home approved ketamine treatment for chronic pain including fibromyalgia,” Weisblum said in a statement Wednesday.

The recent advancement follows positive compliance inspections from state and federal Drug Enforcement Administration authorities, granting Sever Pharma Solutions the required approvals to begin working with ketamine for the implant.

The treatment, which involves subcutaneous injection, is currently undergoing preclinical research to evaluate its safety, a requirement for FDA approval for home use. Silo Pharma is targeting the FDA’s 505(b)(2) pathway for a potentially expedited approval process.

The firm’s approach to the treatment of chronic pain involves the use of subcutaneous injection for administering the implant. The early stages of preclinical research are focused on assessing the drug’s safety profile in accordance with the FDA’s requirements for potential designation as an at-home therapeutic. The company is aiming to utilize the FDA’s 505(b)(2) pathway for a more expedited approval process.

According to Allied Market Research, the market for fibromyalgia treatments was valued at approximately $3.1 billion in 2022 and is expected to grow at a compound annual growth rate of 4% over the next decade. The broader chronic pain market is projected to exceed $140 billion by 2030, signaling market opportunity for SP-26.

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