Pharma Focus Europe

Cessation Therapeutics Granted FDA Fast Track Designation for CSX-1004 in Preventing Fentanyl and Fentanyl Analog Overdose

Wednesday, November 01, 2023

Cessation Therapeutics, Inc. ("Cessation"), a clinical-stage biotechnology company focused on biologics targeting substances of abuse, has announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for CSX-1004. This designation applies to CSX-1004, an experimental therapy designed to prevent fentanyl-related overdoses. CSX-1004 is a human IgG1 monoclonal antibody specifically tailored to fentanyl and its analogs. It functions by capturing fentanyl molecules as they enter the bloodstream, effectively neutralizing them in the blood before they can reach the brain and cause harm.

The Fast Track designation is designed to streamline the development and review process for drugs addressing severe and life-threatening conditions, expediting the potential market entry of investigational products. Benefits of Fast Track designation include regular interactions with the FDA review team and potential eligibility for Accelerated Approval and Priority Review.

Cessation, emphasized the significance of the FDA's Fast Track designation for CSX-1004, recognizing its potential to combat a significant public health crisis responsible for one death every seven minutes in the United States. Barrett expressed optimism about the FDA's decision, emphasizing the urgent need for innovative treatments that can potentially reduce the alarming number of fentanyl-related deaths.

The Fast Track designation was partly based on data from nonhuman primate studies, 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 study (NCT06005402) in healthy volunteers to assess the safety, tolerability, and pharmacokinetics of CSX-1004.



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