As a result of these studies, Accentia BioPharmaceuticals, Inc., obtained a license from the Mayo Clinic to develop the amphotericin B treatment under the name SinuNase™. With an investigational new drug application, Accentia received fast track designation from the US Food and Drug Administration to test the treatment in clinical trials. Results will be unblinded this month.
The Critics Are Skeptical
Meanwhile, critics of the fungal theory worry that practitioners might adopt use of an antifungal agent when only limited data are available to prove effectiveness. Others point to studies by two separate European groups that found that amphotericin B was ineffective in CRS treatment.
The issue is whether this is a universally effective or even appropriate treatment for all forms of CRS, said Bradley F. Marple, MD, Professor of Otolaryngology at University of Texas Southwestern Medical School in Dallas. Unfortunately, we have not yet fully characterized the pathogenesis of CRS. Based on the limited evidence that is currently available, many feel that amphotericin B may be appropriate for a subset of patients with CRS, but not all patients. At present, there are several attractive nonfungal etiologies under investigation that may also act as underlying triggers of CRS, such as bacterial superantigens, biofilms, and allergies. These are all things that could work independently or in conjunction with one another to drive the inflammatory process.