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Romark Announces Clinical Trial Results for New Influenza Drug Presented at IDSA Meeting 2011
Date:10/21/2011

Jason Haffizulla, Harvey Resnick, Aaron Hartman, Stefan Comhaire, Maria Carríon, Matthew Bardin. Presentation Number LB-35, Session 182a: Late Breaker Oral Abstracts - Clinical Virology and Treatment. Saturday, October 22, 2011, 6:30 PM.

About the US Clinical Trial

The clinical trial was conducted in 74 outpatient primary care centers throughout the United States during the 2010-2011 flu season.  624 patients, 12 to 65 years of age, with influenza symptoms were enrolled in the study within 48 hours of symptom onset and received treatment with 300 mg NTZ, 600 mg NTZ or placebo twice daily for 5 days.  Patients who received an influenza vaccine after August 1, 2010 and patients at risk of complications of influenza based upon CDC or IDSA criteria were excluded from participation in the trial. The study was designed according to FDA Guidance and consistent with prior clinical trials of Tamiflu® and Relenza®. The primary efficacy endpoint of the study was time from first dose to alleviation of symptoms (all symptoms absent or mild and remain so for 24 hours).  

Two hundred and fifty-seven (257) of the 624 patients enrolled in the study (41%) had laboratory confirmed influenza infection by RT-PCR or viral culture at baseline. Approximately half of the influenza-infected patients enrolled in the US clinical trial were infected with influenza A subtype H1N1 ("swine flu") with approximately 30% being infected with influenza B and 20% with influenza A subtype H3N2. The trial achieved its primary endpoint showing that influenza-infected patients treated with NT-300 administered 600 mg twice daily for five days experienced statistically significant reduction in time from beginning treatment to alleviation of flu symptoms compared to influenza-infected patients receiving the placebo (P=0.008). Median time to alleviation of symptoms was 95.5 hours for the 600 mg dose group compared to 109.1 hours for the 300 mg do
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SOURCE Romark Laboratories, L.C.
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