TAMPA, Fla., Oct. 21, 2011 /PRNewswire/ -- Romark Laboratories announced that results of a large Phase 2B-3 US clinical trial of its new flu drug, NT-300 (nitazoxanide), will be presented as an oral late-breaking communication at the 49th Annual Meeting of the Infectious Diseases Society of America (IDSA) being held in Boston, October 20-23, 2011.
The clinical trial enrolled 624 patients at 74 outpatient primary care centers throughout the United States during the 2010-2011 flu season. 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).
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.
"These data are encouraging," said Jean-Francois Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of Romark. "We currently have only two drugs to treat influenza, both neuraminidase inhibitors, and resistance is a major concern. There is an urgent need for a new drug with a different mechanism of action for treating influenza."
Data from two other Phase 2 clinical trials, including one clinical trial in children down to 12 months of age, and laboratory studies of the drug's activity against influenza viruses will also be presented at the IDSA meeting. In total, four different communications will be presented. The meeting is attended by infectious disease physicians, scientists and public health personnel from the United States and around the world.
Romark plans to init
|SOURCE Romark Laboratories, L.C.|
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