Sinusitis, inflammation of the sinus passages around the nose and throat, is one of the most common illnesses in the United States, affecting between 30 and 40 million people each year, and triggering between 18 and 22 million doctor visits. Among the symptoms are nasal congestion, thick mucus production, headaches, tenderness in the face, and aching behind the eyes. Chronic sinusitis persists for weeks, months, or longer, causing misery for sufferers. In the most severe cases the sinus cavity clogs, preventing drainage of mucous and making it difficult to breathe through the nose.

Prior to the research on fungal etiology, the prevailing opinion among the healthcare community was that upper respiratory infections such as colds and flu caused chronic sinusitis by damaging the upper respiratory epithelium. Within the last decade, physicians at the Mayo Clinic hypothesized that most cases of chronic sinusitis were caused not by epithelial dysfunction, but by an inflammatory reaction to the presence of fungi in the mucus. This novel idea was initially rejected by medical specialists, but in a few short years, evidence in favor of the fungal etiology of chronic sinusitis has accumulated. Surveys of ear, nose, and throat specialists (ENTs, also known as otolaryngologists) and allergists revealed that a large number of the specialists treating this disease have adopted the theory that an inflammatory response to fungus in susceptible patients (almost 10%) is the cause of Chronic Sinusitis.

Accentia Biopharmaceuticals has conducted three surveys, presented at a recent American College of Allergy, Asthma and Immunology symposium. The surveys revealed that prevailing perceptions among ENT’s regarding the possible fungal cause of chronic sinusitis, especially for patients who do not benefit from surgery to correct chronic sinusitis. This group of patients is classified as “surgery refractory.”

The first two surveys suggested that ENTs in the United States saw up to twice as many patients with chronic sinusitis as their counterparts in Germany, France, and the United Kingdom. Approximately 25% of their chronic sinusitis patients were refractory to surgery, meaning their condition does not improve after an operation to remove sinus tissue. In addition, 90% of US and EU (European Union) specialists expressed dissatisfaction with current treatment options for chronic sinusitis, and acknowledged the significant impact to quality of life associated with this condition.

The third survey polled eighty American ENTs and allergists to determine the physicians’ prevalent belief regarding the etiology, or cause of chronic sinusitis. In this survey, three-quarters of physicians (75%) attributed the root cause of chronic sinusitis to a fungal infection, and 84% believed that surgery refractory patients were more likely to fall into the fungal etiology category. Sixty-nine percent of specialists surveyed considered intranasal antifungal drug therapy to be an appropriate treatment for chronic sinusitis patients, with 74% supporting this approach for surgery-refractory patients.

“Fungal etiology is gaining greater acceptance among U.S. and European physicians,” noted Angelos Stergiou, MD, Medical Director at Accentia Biopharmaceuticals. Accentia is currently planning to test the effects of SinuNase™, an intranasal form of Amphotericin B, in patients with chronic sinusitis. SinuNase belongs to a class of medicines known as anti-fungals.

The seriousness of chronic sinusitis, and the potential of SinuNase to become the first approved treatment for treating this condition prompted Accentia to seek “Fast Track” status for this drug. In
response to this application, the U.S. Food and Drug Administration granted “Fast Track” status for SinuNase in April 2006. For more information on the clinical trials and their location, please