Cessation Therapeutics Receives FDA Fast Track Designation for CSX-1004 for Prevention of Fentanyl and Fentanyl Analog Overdose
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星期二, 十月 31, 2023
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Cessation Therapeutics, Inc. (“Cessation”), a clinical-stage biotechnology company advancing biologics that target substances of abuse, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CSX-1004, an investigational therapy for prevention of fentanyl-related overdose.
Key Points:
- Cessation Therapeutics, Inc. (“Cessation”), a clinical-stage biotechnology company advancing biologics that target substances of abuse, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CSX-1004, an investigational therapy for prevention of fentanyl-related overdose.
- 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.
- Cessation has initiated a Phase 1a, first-in-human study (NCT06005402) to evaluate the safety, tolerability, and pharmacokinetics of CSX-1004 in healthy volunteers.