SinuNase (Amphotericin B)
Nasal Lavage for Chronic Sinusitis

SinuNase™ has not yet been approved by the U.S. FDA or any international regulatory agency, and this product is likely to require additional clinical trials before potential approvals are granted.

SinuNase™ Therapy for Chronic Rhinosinusitis

Accentia holds the worldwide, exclusive commercial rights to SinuNase (topical amphotericin B 0.01% suspension), an intranasal, low-dose antifungal product, as granted by the Mayo Clinic. SinuNase is especially unique because it is the first product to target what is believed to be the true cause of chronic sinusitis: fungal-induced inflammation. SinuNase is self-administered into a patient's nasal cavity and holds the potential to be the first product approved for treating chronic sinusitis.

Currently, there are no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMEA) approved treatments for chronic sinusitis, which affects more than 60 million sufferers in the U.S. and Europe. SinuNase is the only intranasal, anti-fungal chronic sinusitis product that has been submitted as an Investigational New Drug (IND) to the FDA, and while SinuNase failed to achieve its primary endpoint in its initial Fast-Track pivotal Phase 3 clinical trial, Accentia found certain encouraging results that warrant further development. Accentia is continuing to analyze these results to determine the optimal course of future clinical development of SinuNase.

What is Chronic Sinusitis?

Chronic Sinusitis is a debilitating disease with common symptoms including severe nasal congestion, sinus headache, production of thick mucus, runny nose, loss of smell, and chronic inflammation leading to polyps, which are small growth in the nasal passages that hinder breathing. Chronic sinusitis can also result in opportunistic bacterial infections, acutely exacerbating those symptoms and often bringing patients to medical attention for the first time. Historically, chronic sinusitis has been treated relatively ineffectively with anti-bacterials, steroids and surgery.

What Causes Chronic Sinusitis?

Since 1999, a comprehensive body of basic and clinical research performed at the Mayo Clinic has indicated that chronic sinusitis is an immune reaction caused by fungus in susceptible patients (approximately 10% of the population). Researchers at Mayo Clinic determined that chronic sinusitis is caused by a normally innocuous non-invasive mold in the mucus, but which in chronic sinusitis patients elicits a destructive, inflammatory response. This eosinophilic inflammatory response is confirmed by testing for the presence of eMBP (eosinophilic major basic protein), which is a toxic protein released by inflammatory cells in response to the fungi.

SinuTest™: Diagnostic for Chronic Sinusitis

Accentia has the exclusive commercial rights in the U.S. to the patented diagnostic, SinuTest™, which is a diagnostic used to measure eMBP (eosinophilic major basic protein) in the nasal mucin of the suspected chronic sinusitis patients. SinuTest is the only confirmatory lab test available for the diagnosis of chronic sinusitis, and it is currently being marketed by Accentia to Ear, Nose and Throat Specialists (ENTs) and Allergy Specialists. SinuTest is expected to provide physicians with a tool to predict those patient candidates best suited to benefit from treatment with SinuNase.