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