The company believes SP-26 “has the potential to be the first at-home approved ketamine treatment for chronic pain including fibromyalgia.”
Silo Pharma, a developmental-stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, recently announced an update on its dosage and time-release ketamine-loaded implant, designated as SP-26.
In collaboration with Silo’s contract development and manufacturing partner, Sever Pharma Solutions, SP-26 is advancing through analytical testing and small batch pre-clinical proof-of-concept extrusion trials to determine drug release and stability, according to Silo.
SP-26 is being developed as a potential at-home pain-relief treatment for fibromyalgia and other chronic pain conditions.
“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 company said in a news release. “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, the company noted.
“Many chronic pain sufferers are seeking a non-opioid treatment that offers relief,” said Eric Weisblum, CEO of Silo Pharma. “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 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, according to Allied Market Research.