Biopharmaceutical company Romark Laboratories has commenced patient enrolment in a Phase III trial of new influenza drug NT-300 (nitazoxanide).

The trial will enrol 1,400 patients with fever and other symptoms of influenza.

Patients will be randomised with either NT-300, placebo (sugar pill), oseltamivir (Tamiflu) or NT-300 plus oseltamivir.

The primary objectives of the study are to demonstrate whether NT-300 reduces the duration of symptoms compared to treatment with placebo, and if NT-300 co-administered with oseltamivir reduces the duration of symptoms compared to NT-300 alone and oseltamivir alone.

Romark chairman and chief science officer Dr Jean-Francois Rossignol said the trial is designed in such a way that the resulting data supports an NT-300 marketing application approval for the treatment of influenza.

"We are also addressing the opportunity to combine treatment with NT-300 and oseltamivir in an effort to further improve treatment outcomes and mitigate the risk of oseltamivir resistance," Rossignol said.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The study commenced in the US and will be continued in Australia and New Zealand in the southern hemisphere. It is expected to be completed during the 2013-2014 flu season in the northern hemisphere.

Upon the completion of the trial, the company anticipates seeking FDA marketing approval for NT-300, administered alone or in combination with oseltamivir, as a treatment of acute uncomplicated influenza.

The US Department of Health and Human Services, Office of the Assistant Secretary of Preparedness and Response and the Biomedical Advanced Research and Development Authority funded the study under a contract valued at up to $44m.

Image: TEM of negatively stained influenza virions, magnified approximately 100,000 times. Photo: Cynthia Goldsmith.