Sucampo Pharmaceuticals, a global pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for cobiprostone, a locally acting chloride channel activator, for the prevention of oral mucositis.
The FDA has also accepted the company’s Investigational New Drug (IND) application to initiate a phase 2 clinical trial of cobiprostone for the prevention of oral mucositis in patients suffering with head and neck cancer receiving concurrent radiation and chemotherapy.
The FDA established the Fast Track Designation process to facilitate the development and expedite the review of drugs that have the potential to treat serious conditions and address an unmet medical need.
Fast Track designated programs are afforded greater access to the FDA and may be eligible for accelerated approval and priority review, thereby expediting the FDA review process.
Sucampo plan to initiate a Phase 2 study for cobiprostone this year
“Oral mucositis is a severe condition that affects patients receiving radiation and chemotherapy for the treatment of head and neck cancer, and for which there are no approved drugs in the U.S.,” said Peter Greenleaf, Chief Executive Officer of Sucampo. “In the U.S., there are approximately 60,000 new patients who are diagnosed with head and neck cancer every year, and there is a significant need for new strategies to address the risk of oral mucositis associated with the treatment of the cancer. With FDA Fast Track Designation, we will be able to interact more frequently with the agency as we advance cobiprostone, which potentially will be eligible for accelerated approval and priority review. We plan to initiate a proof-of-concept, Phase 2 study for cobiprostone in oral mucositis by the end of the quarter.”
