Oral mucositis is a nearly inevitable complication for patients undergoing chemotherapy or radiation treatment for head or neck cancer. Roughly 100 percent of these patients develop oral mucositis, which is characterized by painful sores in the mouth, infection, and the inability to chew or swallow. Some patients’ symptoms are severe enough for them to discontinue cancer therapy. The standard treatment, “magic mouthwash”—a combination of therapeutics such as lidocaine, saline, and antibiotics–contains a different set of ingredients from one hospital to another. It is also typically used only after oral mucositis has developed. There is a large, unmet clinical need for a preventive oral mucositis treatment.
Now, scientists in Europe are excited about a new product that has been clinically shown to prevent oral mucositis from developing in the first place. MuGard, developed by Dallas-based Access Pharmaceuticals (ACCP), is a mucoadhesive rinse that forms a protective coating over the oral mucosa. Access Pharmaceuticals has announced that its European partner, SpePharm, is collecting data from a post-approval study of MuGard. Patients in the UK study started MuGard one week before beginning radiation therapy, then took it throughout the following six weeks of therapy. Out of the 140 patients who have participated in the study to date, none have developed oral mucositis. Access Pharmaceuticals plans to enroll approximately 280 patients in the multi-center study.
The potential market for oral mucositis preventive therapy in patients with head or neck cancer is estimated to be over $5 billion worldwide. If MuGard continues to perform strongly in clinical studies, it has the potential to make a large impact in the market. MuGard has already earned 510(k) marketing approval from the U.S. Food and Drug Administration. SpePharm has launched the product in several European countries, including the UK, Germany, and Italy.
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