Research Finding in Treatment of Rotavirus Could Have Worldwide Effect on Health of Children

TAMPA, Fla. -- Romark Laboratories announces that findings from research in the use of its drug, nitazoxanide, for the treatment of rotavirus could substantially reduce the impact of this viral disease affecting mostly children. Rotavirus is the leading cause of morbidity and mortality in children younger than 5 years of age, resulting in an estimated 500,000 deaths annually worldwide.

In a research paper published today in The Lancet, an internationally recognized medical journal, researchers reported finding that a three-day course of treatment with nitazoxanide can substantially reduce the duration of severe dehydrating rotavirus diarrhea and gastroenteritis in children. The results of the research, conducted at CairoUniversity's Children's Hospital in Egypt, were published online in The Lancet to coincide with the 7th International Rotavirus Workshop in Lisbon, PortugalJune 12-13, 2006.

Worldwide, more than 1 in 40 children under the age of five are hospitalized annually because of rotavirus diarrhea. The medical and societal costs of rotavirus in the U.S. are estimated at more than $1 billion annually. Currently, there is no effective treatment for rotavirus.

"These findings could have worldwide impact," said Jean-Francois Rossignol, chairman and chief science officer of the Romark Institute for Medical Research.

Rossignol said the duration of rotavirus illness was reduced by almost two days in children treated with nitazoxanide, and no significant side effects were reported. "These results are encouraging and might lead us to think about new approaches to managing rotavirus disease in children," he added.

Romark presently markets nitazoxanide under the trade name Alinia, which has been approved by the Food and Drug Administration for the treatment of diarrhea in children and adults caused by Cryptosporidium or Giardia. Romark is also studying the application of nitazoxanide for the treatment of Clostridium difficile, hepatitis C and hepatitis B.

Marc Ayers, president and CEO of Romark, said the company is pursuing additional studies to have Alinia licensed for treating rotavirus gastroenteritis in children. "We are excited about the opportunity to reduce the burden of illness associated with this disease," he added.

Source: Romark Laboratories