22 Jul Promising New Influenza Drug Reduces Flu Symptoms and Viral Shedding
MedicalResearch.com Interview with:
Prof. Jean-Francois Rossignol, FRSC, FRCPath
Romark Laboratories, LC
MedicalResearch: What are the main findings of the study?
Prof. Rossignol: Nitazoxanide, a new orally administered drug in development for treating influenza, reduced the duration of symptoms of uncomplicated influenza compared to a placebo. The drug also reduced viral shedding. Side effects were similar for the drug and placebo treatment arms. The study was designed and conducted in compliance with FDA guidelines for studying new drugs for influenza.
MedicalResearch: Were any of the findings unexpected?
Prof. Rossignol: In contrast to existing drugs, nitazoxanide reduced the duration of symptoms in patients with flu-like symptoms that were not diagnosed with influenza. The activity in patients without confirmed flu may be related to broad-spectrum antiviral activity against other respiratory viruses, which has been observed in laboratory studies. This finding could also potentially reflect a lack of sensitivity of the diagnostic techniques.
MedicalResearch: What should clinicians and patients take away from your report?
Prof. Rossignol: There is an important need for new drugs that could be used to treat seasonal and pandemic influenza including viruses that may be resistant to existing drugs. Nitazoxanide, an orally administered drug with a new mechanism of action against influenza viruses, could be an important addition to the arsenal of drugs currently used to treat influenza.
MedicalResearch: What recommendations do you have for future research as a result of this study?
Prof. Rossignol: A large global Phase 3 clinical trial is being conducted to support the licensure of nitazoxanide for treatment of uncomplicated influenza. This clinical trial is evaluating nitazoxanide alone and in combination with oseltamivir (Tamiflu®, Roche). Studies in pediatric patients under 12 years of age and in hospitalized patients are also warranted.
Effect of nitazoxanide in adults and adolescents with acute uncomplicated influenza: a double-blind, randomised, placebo-controlled, phase 2b/3 trial
Jason Haffizulla MD,Aaron Hartman MD,Melanie Hoppers MD,Harvey Resnick MD,Steve Samudrala MD,Christine Ginocchio PhD,Matthew Bardin PharmD,Prof Jean-François Rossignol MD,for the US Nitazoxanide Influenza Clinical Study Group
The Lancet Infectious Diseases – 1 July 2014 ( Vol. 14, Issue 7, Pages 609-618 )