LOS ANGELES- In a significant step towards innovating chronic pain management, developmental-stage biopharmaceutical company Silo Pharma, Inc. (Nasdaq: SILO) has reported notable progress in the development of SP-26, a ketamine-loaded implant designed for home treatment of fibromyalgia and other chronic pain conditions.
Working collaboratively with Sever Pharma Solutions, Silo Pharma is conducting analytical testing and pre-clinical trials to ascertain the drug release and stability of the implant. This phase is crucial for evaluating the potential effectiveness and safety of the treatment.
Eric Weisblum, CEO of Silo Pharma, emphasized the company’s commitment to addressing the urgent need for non-opioid pain relief options. “Based on our current findings, SP-26 stands a chance to become the first at-home approved ketamine treatment for chronic pain, including fibromyalgia,” Weisblum stated on Wednesday.
This advancement follows after positive compliance inspections from both state and federal Drug Enforcement Administration authorities, which have granted Sever Pharma Solutions the necessary approvals to commence work with ketamine for the implant.
The treatment, involving a subcutaneous injection method for implant administration, is presently in the preclinical research phase. This stage is essential to evaluate safety, a prerequisite for gaining FDA approval for home use. Silo Pharma is specifically targeting the FDA’s 505(b)(2) pathway, which could potentially accelerate the approval process.
The firm’s approach, leveraging subcutaneous injection for implant delivery, is currently under rigorous evaluation to ensure compliance with FDA’s stringent requirements for at-home therapies. The objective is to expedite the approval process through the FDA’s 505(b)(2) pathway.
Market research by Allied Market Research indicates a promising future for this venture. In 2022, the market for fibromyalgia treatments was valued at approximately $3.1 billion, with expectations of a 4% compound annual growth rate over the next decade. Furthermore, the broader chronic pain market is projected to surpass $140 billion by 2030, presenting a substantial market opportunity for SP-26.
