November 7, 2006

Accentia Biopharmaceuticals will begin enrolling patients in its Phase III study of SinuNase, including patients with severe chronic sinusitis refractory to sinus surgery. The company believes that SinuNase, which has received fast-track status from the FDA, is the first product candidate to be in a Phase III trial for chronic sinusitis, according to the company. Despite the fact that chronic sinusitis is the most common chronic respiratory disease, there is currently no approved prescription pharmaceutical for chronic sinusitis, according to the company.

The trial will be a 16-week, double-blinded comparison with 300 patients randomized between SinuNase (intranasal lavage of 0.01 percent amphotericin B) and placebo, with the primary endpoint being the resolution of the key cardinal symptoms of chronic sinusitis. Secondary endpoints include endoscopy scores and sinus mucosal thickening on CT scan.

SinuNase is an amphotericin B suspension that is self-administered into a patient's nasal cavity. Historically, the treatment of chronic sinusitis has largely focused on addressing the symptoms of the condition through acute antibiotic therapy, intranasal or oral corticosteroids and sinus surgery, according to Accentia. Intranasal and oral corticosteroids, which are potent anti-inflammatory hormones, have been used to reduce the inflammation that plays a role in chronic sinusitis, but oral corticosteroids can cause serious side effects and must be used cautiously in some patients.