Cessation Therapeutics, Inc. announced that the FDA granted Fast Track designation for CSX-1004, an investigational therapy for prevention of fentanyl-related overdose. CSX-1004 is a human IgG1 monoclonal antibody specific for fentanyl and fentanyl analogs and works by sequestering fentanyl molecules as they enter the bloodstream, effectively neutralizing them in the blood before they reach the brain and preventing them from exerting their harmful effects.
Fast Track designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an investigational product can reach the market expeditiously. Features of Fast Track designation include frequent interactions with the FDA review team, and if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.
Fast Track designation was based, in part, on nonhuman primate data demonstrating that a single dose of CSX-1004 can block the life-threatening, respiratory depressant effects of high doses of fentanyl for up to 28 days. Cessation has initiated a Phase 1a, first-in-human study (NCT06005402) to evaluate the safety, tolerability, and pharmacokinetics of CSX-1004 in healthy volunteers.
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