- The FDA grants Fast Track status to Sucampo Pharmaceuticals' (NASDAQ:SCMP) cobiprostone for the prevention of oral mucositis, inflammation of the oral mucosa caused by chemotherapy or radiotherapy characterized by redness of the mucous membranes or ulcerations.
- Cobiprostone is a fatty acid called a prostone. It is a chloride channel activator that has demonstrated protection against ulcer formation. It is currently in Phase 2 development.
- Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
Sucampo's cobiprostone Fast Track'd for prevention of oral mucositis
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