FDA grants Accentia Fast Track status for SinuNase

By E. Janene Geiss

Philadelphia, April 12 - Accentia Biopharmaceuticals, Inc. said Wednesday that it has been notified that the Food and Drug Administration granted fast track status to SinuNase, the company's intranasal Amphotericin B formulation.

The company believes SinuNase is the first and only drug candidate for chronic sinusitis to receive fast track status from the FDA, according to a company news release.

The FDA designates "fast track" to new drugs that the agency feels has the potential to address unmet medical needs by treating serious or life-threatening conditions.

With fast track status, Accentia said it is now eligible to submit its New Drug Application on a rolling basis, allowing the FDA to review sections of the application in advance of receiving Accentia's full submission, and permitting Accentia to apply for expedited review of its application.

"Chronic sinusitis represents a substantial unmet clinical need, causing significant morbidity and expense," Frank E. O'Donnell Jr., chairman and chief executive officer, said in the release.

Officials said 31 million people are affected with chronic sinusitis in the United States alone, and about 500,000 patients 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 health care costs of chronic sinusitis are estimated at more than $5 billion a year, officials said.

Accentia is preparing to begin its phase 3 placebo-controlled clinical trial with SinuNase to treat post-surgical patients suffering from recurrent chronic sinusitis.

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.

Accentia is a Tampa, Fla., biopharmaceutical company focused on the development and commercialization of late-stage clinical products in the therapeutic areas of respiratory disease and oncology.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.