CTD Holdings Receives FDA Fast Track Designation for Trappsol(R) Cyclo(TM)

CTD Holdings, Inc. (OTCQB: CTDH), a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Trappsol® Cyclo™ for the treatment of systemic Niemann-Pick Disease Type C (NPC), a rare and fatal genetic disease. Trappsol® Cyclo™ is the Company’s proprietary formulation of hydroxypropyl beta cyclodextrin in development for the treatment of NPC; it has previously been designated an Orphan Drug by the FDA and the European Medicines Agency.
The FDA’s Fast Track process is designed to facilitate the development and expedite the review of drugs that are intended to treat serious conditions and that demonstrate the potential to address an unmet medical need. Its purpose is to get important new drugs to patients earlier. Fast Track designation allows for more frequent interactions with the FDA during all aspects of a drug’s development to ensure the collection of appropriate data needed to support approval, and may result in eligibility for priority review and accelerated approval.
“We thank the FDA for granting Fast Track designation to Trappsol® Cyclo™ as a treatment for Niemann-Pick Disease Type C and look forward to working with the Agency as it reviews our clinical findings and eventual expected marketing application,” said N. Scott Fine, Chairman and CEO of CTD. “We believe this is a very positive step for our development program that will support our efforts to make Trappsol® Cyclo™ available to NPC patients and their families as quickly as possible. Based on the data generated to date from this program, we believe Trappsol® Cyclo™ has significant potential in the treatment of NPC.”
NPC is a systemic disease that affects the brain, liver and other organs through abnormal accumulation of cholesterol in cells. It impacts primarily children, but is increasingly diagnosed in older patients who may live with this disability for many years.
About the Company:
CTD Holdings, Inc. is a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of disease. The company’s Trappsol® Cyclo™, an orphan-drug-designated product candidate in the United States and Europe, is in development to treat Niemann-Pick Disease Type C, a rare and fatal genetic disease. Additional indications for the active ingredient in Trappsol® Cyclo™ are also in development. For additional information, visit the company’s website: www.ctd-holdings.com
Safe-Harbor Statement:
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