Creative Medical Technology Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead investigational therapy, CELZ-201-DDT. This therapy is being developed for the treatment of degenerative disc disease (DDD), which is a major cause of chronic lower back pain and disability.
The FDA's Fast Track designation is granted to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need. This designation positions CELZ-201-DDT among therapies that have the potential to provide significant benefits over existing treatments. It facilitates more frequent interactions with the FDA and potentially qualifies for accelerated approval and priority review.
This regulatory milestone underscores the potential of CELZ-201-DDT to address a critical unmet medical need in pain management. The Fast Track designation is expected to streamline the development pathway, potentially accelerating the availability of this novel, non-opioid therapeutic option for patients suffering from chronic lower back pain.
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