The agency has also accepted the company’s investigational new drug (IND) application to begin a Phase II trial of cobiprostone to prevent oral mucositis in patients suffering with head and neck cancer receiving concurrent radiation and chemotherapy.
Sucampo CEO Peter Greenleaf said: "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 US.
"In the US, 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.
The company intends to begin a proof-of-concept, Phase II trial for cobiprostone in oral mucositis by the end of the quarter.
Cobiprostone works to stimulate and protect the mucosal barrier function and the product is currently being developed to treat non-erosive reflux disease (NERD), a major subtype of gastroesophageal reflux disease (GERD).