Healthcare Industry News:  fast track designation 

Biopharmaceuticals FDA

 News Release - April 16, 2007

FDA Approves Fast Track Designation for Naryx Pharma's Product for Chronic Sinusitis

SANTA BARBARA, Calif.--(HSMN NewsFeed)--Naryx Pharma, Inc. announced today that the FDA has granted a request for fast track designation of SPRC-AB01, an antibiotic product being developed for the treatment of chronic sinusitis in patients who have undergone previous sinus surgical procedures.

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. Naryx is now eligible to submit a New Drug Application (NDA) on a rolling basis and may apply for expedited review of its NDA.

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.

Robin Campbell, Ph.D., President and CEO of Naryx Pharma, stated, "Over 30 million people in the U.S. are diagnosed with chronic sinusitis and a substantial proportion continue to have problems even after attempts at surgical correction. We are pleased that the FDA has recognized that chronic sinusitis that persists after sinus surgery is a serious disease, and that SPRC-AB01 has the potential to address an unmet medical need."

Naryx Pharma is currently conducting a Phase 2b study comparing SPRC-AB01 to placebo in this population of patients. More information about the study, including clinical study sites, can be obtained at

About Naryx Pharma

Naryx is a privately-held company dedicated to developing innovative therapies for chronic sinusitis based on advances in the targeted delivery of medications. Chronic sinusitis is a disease that afflicts over 30 million people in the United States alone. The Company will focus on obtaining marketing approvals for its promising intellectual property portfolio of intranasal drug formulations.

Source: Naryx Pharma

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