Silo dosage and time-release formulation aim for potential first at-home Ketamine therapeutic
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.
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.1 The broader chronic pain market is projected to exceed $140 billion by 2030.2
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1
2 Spherical Insights: Global Chronic Pain Market Size…, 2023
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