Silo Pharma, Inc. unveils progress on SP-26, a revolutionary ketamine-loaded implant designed for at-home pain relief, particularly targeting fibromyalgia and chronic pain conditions.
In collaboration with Sever Pharma Solutions, Silo's development partner, SP-26 is undergoing crucial analytical testing and pre-clinical trials. With recent approvals from state and federal Drug Enforcement Administration (DEA) authorities, the project is set to enter the stage of loading ketamine into the implant.
The dosage and time-release implant formulation will undergo meticulous study using the subcutaneous injection method. Early preclinical research is focused on ensuring the drug's safety profile aligns with FDA requirements for potential at-home therapeutic designation.
Silo Pharma plans to navigate the FDA's streamlined 505(b)(2) pathway for the approval of SP-26.
Eric Weisblum, CEO of Silo Pharma, expressed optimism, stating, "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, valued at USD 3.1 billion in 2022, is projected to witness a compound annual growth rate of 4 percent over the next decade. The broader chronic pain market is anticipated to surpass USD 140 billion by 2030.
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