New Chronic Sinusitis Antibiotic Receives Fast Track Designation from the FDA

The FDA has approved a Fast Track Designation request by Naryx Pharma, Inc. for an antibiotic, SPRC-AB01 for the treatment of chronic sinusitis for patients who have undergone previous sinus surgical procedures.

Sinusitis affects more than 37 million people in the United States each year. Under the FDA Modernization Act of 1997, a new drug may be designated “Fast Track” if the agency feels that the drug candidate has the potential to address an unmet medical need by treating a serious or life-threatening condition.

In its response to Naryx’s application, The Division of Anti-Infective and Ophthalmology Products acknowledged that chronic sinusitis that persists after sinus surgery has an enduring adverse impact on the day-to-day functioning of patients who suffer from the condition. Moreover, there are no currently approved medical therapies for the treatment of chronic sinusitis in post-surgical patients, and information from clinical trials suggests that SPRC-AB01 relieves the symptoms of chronic sinusitis in these patients.

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