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FEN-CRM197 conjugate (also known as FEN-CRM) is an investigational conjugate vaccine designed to treat opioid use disorder (OUD) and prevent fentanyl overdose. Developed by ARMR Sciences and licensed from the University of Houston, the vaccine consists of a fentanyl-like hapten (glutaryl fentanyl) chemically conjugated to CRM197, a genetically detoxified mutant of diphtheria toxin that serves as a carrier protein. When administered, typically alongside an adjuvant such as dmLT (double-mutant heat-labile toxin) or alum, the vaccine stimulates the immune system to produce high-affinity anti-fentanyl antibodies. These antibodies bind to fentanyl in the bloodstream, sequestering the drug and preventing it from crossing the blood-brain barrier. By blocking fentanyl from reaching the brain, the vaccine prevents the drug's psychoactive, analgesic, and respiratory-depressive effects, thereby reducing the risk of fatal overdose and preventing relapse in individuals with OUD. It is currently undergoing Phase 1 clinical evaluation.
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