Romark Laboratories announced that it has begun enrolling patients in a global Phase 3 clinical trial of NT-300 (nitazoxanide) for treatment of acute uncomplicated influenza.
The Phase 3 clinical trial has been initiated in the United States, will continue in Australia and New Zealand in the southern hemisphere and is expected to be completed during the 2013-2014 flu season in the northern hemisphere.
"There is a pressing need for new drugs to treat influenza," said Jean-Francois Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of Romark. "This trial is designed to provide data required to support an application for approval to market NT-300 for 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." The clinical trial will enroll 1,400 patients with fever and other symptoms of influenza. Patients are being randomly assigned to receive treatment with either NT-300, placebo (sugar pill), oseltamivir (Tamiflu) or NT-300 plus oseltamivir. The primary objectives of the study are to demonstrate that NT-300 reduces the duration of symptoms compared to treatment with placebo and NT-300 co-administered with oseltamivir reduces the duration of symptoms compared to NT-300 alone and to oseltamivir alone.
After completing this clinical trial, Romark plans to submit a New Drug Application seeking FDA approval to market NT-300 administered alone or in combination with oseltamivir as a treatment of acute uncomplicated influenza.
Currently, there are only two classes of drugs approved in the United States for treating influenza, and only the neuraminidase inhibitors, oral Tamiflu (oseltamivir) and inhaled Relenza (zanamivir), are recommended for use. There has not been a new drug approved in the United States for treating influenza since Tamiflu and Relenza were approved in 1999. New drugs with different mechanisms of action could be important in overcoming drug resistance and providing better treatment for patients with influenza.
The Phase 3 clinical trial of NT-300 will be fully funded by the U.S.
Department of Health and Human Services (HHS)/Office of the Assistant Secretary of Preparedness and Response (ASPR)/Biomedical Advanced Research and Development Authority (BARDA) under contract HHSO100201300004C. The value of the cost plus fixed-fee contract is up to $44 million.