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New Sinusitis Treatment Gets Fast Track Status from FDA

SinuNase, an intranasal Amphotericin B formulation by Accentia Biopharmaceuticals for the treatment of chronic sinusitis, has been given Fast Track status by the U.S. Food and Drug Administration. According to Accentia, SinuNase is the first and only drug candidate for chronic sinusitis to receive Fast Track status from the FDA.

Because of the FDA Modernization Act of 1997, a new drug can be given Fast Track status if the FDA feels that the drug candidate has the potential to address unmet medical needs by treating serious or life-threatening conditions. Because SinuNase has been given this status, Accentia can now submit a new drug license application (NDA) on a rolling basis, allowing the FDA to look over sections of the NDA before receiving Accentia's full submission. This can greatly expedite review of Accentia's NDA.

"Chronic sinusitis represents a substantial unmet clinical need, causing significant morbidity and expense, stated Frank E. O'Donnell, Jr. M.D., Accentia's Chairman and CEO. "There is no approved pharmaceutical for the treatment of chronic sinusitis, despite 31 million affected patients in the U.S. alone, and about 500,000 patients who resort to sinus surgery each year in an attempt to control their chronic symptoms. These patients have chronic obstruction of the sinuses, which predisposes them to acute sinusitis, a bacterial super-infection for which more than 40 million antibiotic prescriptions are dispensed annually. The healthcare cost of chronic sinusitis is estimated at greater than $5 billion a year."

Accentia is now preparing to finish its third phase of clinical trials with SinuNase to treat post-surgical patients suffering from recurrent chronic sinusitis.

By the FDA giving fast track status to a sinusitis treatment drug, it shows how huge a problem chronic sinusitis is. Sinusitis is one of the most common diseases suffered by AMericans and affects almost 31 million patients in the U.S. Currently there is no cure for sinusitis but research is being conducted by several biopharmaceutical companies like Accentia to help sinusitis sufferers find relief.


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