Silo Pharma with Sever Pharma Solutions Obtains Regulatory Approval to Conduct the Development of Ketamine Implant for Fibromyalgia
Shots:
- Sever Pharma Solutions has obtained state and federal DEA approval to work with ketamine and load it into Silo Pharma's implant, SP-26, following positive compliance inspections
- SP-26 is developing through analytical testing and small batch pre-clinical PoC extrusion trials to assess drug release and stability. The dosage and time-release implant formulation of SP-26 will be studied using SC injection
- The early preclinical research for SP-26 will emphasize on the drug's safety profile, aligning with FDA requirements for potential at-home therapeutic designation. Silo also anticipates the US FDA approval through the streamlined 505(b)(2) pathway
Ref: Globe Newswire | Image: Silo Pharma
Related News:- Tonix Pharmaceuticals Reports the Results for TNX-102 SL in P-III Trial for the Management of Fibromyalgia
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
