Accentia sinus drug fast tracked

SinuNase is an intranasal Amphotericin B formulation, which the company believes is the first and only drug candidate for chronic sinusitis (CS) to receive fast track status. By putting a drug in this regulatory category, the FDA is signifying its confidence that the treatment has the potential to address unmet medical needs by treating serious or life-threatening conditions.

This status will allow Accentia to submit a new drug license application (NDA) on a rolling basis, allowing the FDA to review sections of the NDA in advance of receiving Accentia’s full submission, and permitting Accentia to apply for expedited review of its NDA.

Dr Frank O’Donnell, Jr., Accentia’s chairman and CEO, said; “There is no approved pharmaceutical for the treatment of chronic sinusitis, despite 31 million affected patients in the US 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 chairman said the estimated cost to the US healthcare system for this illness was in the region of $5 billion a year.

Accentia is preparing to commence its phase III placebo-controlled clinical trial with SinuNase to treat post-surgical patients suffering from recurrent CS. The study is intended to be a four-month double-blinded comparison of symptomatic relief in patients randomized for treatment with either SinuNase or a placebo control.