Silo Pharma & Partner Receive Regulatory Approval to Begin Development of Ketamine Implant for Fibromyalgia
Silo Pharma, Inc. recently announced an update on its dosage and time-release ketamine-loaded implant, designated as SP-26, which is being developed as a potential at-home pain relief treatment for fibromyalgia and other chronic pain conditions. In collaboration with Sever Pharma Solutions, Silo’s contract development and manufacturing partner, SP-26 is advancing through analytical testing and small batch pre-clinical proof of concept extrusion trials to determine drug release and stability.
Following recent positive compliance inspections from the state and federal Drug Enforcement Administration (DEA) authorities, Sever Pharma Solutions now has the required approval from such state and federal DEA authorities to commence working with ketamine and loading it into the implant. The dosage and time-release implant formulation will be studied utilizing the subcutaneous injection method.
Early preclinical research will focus on the drug’s safety profile with respect to the FDA’s requirements for potential designation as an at-home therapeutic. Silo intends to pursue the FDA’s streamlined 505(b)(2) pathway for approval of SP-26.
Eric Weisblum, Chief Executive Officer of Silo Pharma, said “Many chronic pain sufferers are seeking a non-opioid treatment that offers relief. 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.”
The expanding fibromyalgia market was valued at approximately $3.1 billion in 2022 and is projected 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.
Silo Pharma Inc. is a development-stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as PTSD, Alzheimer’s disease, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the healthcare industry. For more information, visit www.silopharma.com
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