TAMPA, Fla., Nov. 18 /PRNewswire/ -- Romark Laboratories announced completion of a prospective, randomized, double-blind clinical trial comparing Alinia (nitazoxanide) to metronidazole (standard of care) in treating hospitalized adults with Clostridium difficile-associated disease.
The study successfully achieved its primary objective with an 89.5% response rate at study day 8 in nitazoxanide-treated patients compared to 82.4% for metronidazole-treated patients (difference: +7.1%, 95% confidence interval: -7%, +26%).
One-hundred and forty-two patients were enrolled in the study and received either metronidazole 250 mg four times per day for 10 days or nitazoxanide 500 mg twice per day for either 7 or 10 days. Response was evaluated on study days 8 and 31. Patients treated with 10 days of nitazoxanide showed a lower recurrence rate (12.5%) than patients treated with metronidazole for 10 days (28.6%) or nitazoxanide for 7 days (25%), although the differences in recurrence rates were not statistically significant.
"These are encouraging results," said Daniel Musher, M.D., Head of Infectious Diseases at the Michael E. DeBakey Veterans Affairs Medical Center and Professor of Medicine at Baylor College of Medicine. Dr. Musher was lead investigator for the study and was involved in the design of the study protocol. "There has been a remarkable lack of activity in developing new drugs for treating this disease considering its importance," added Musher. "There are increasing reports of treatment failures and new toxigenic strains as well as continuing concerns over the selection of vancomycin-resistant bacteria. It is important that there be other options for treatment."
Romark plans to initiate a final clinical trial early in 2006 designed to obtain data required for FDA approval to market Alinia for treating Clostridium difficile-associated disease.
Clostridium difficile is a leading cause of diarrhea and colitis contracted in hospitals or long-term care facilities and associated with the use of antibiotics. The disease often affects elderly and debilitated patients and can be quite serious. The only two treatments available in the United States are metronidazole and vancomycin, and vancomycin is typically reserved because of its cost and the risk of selecting vancomycin-resistant bacteria.
About Alinia
Alinia (nitazoxanide) is indicated in the United States for treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum in patients 1 year of age and older. Alinia has not been shown to be superior to placebo for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients. The most common adverse events reported by patients receiving Alinia have been abdominal pain, diarrhea, headache and nausea. In controlled trials, the frequency of these events has been similar to patients receiving a placebo. Alinia is under development in the United States for treatment of Clostridium difficile-associated diarrhea, Crohn's disease and chronic hepatitis C.
About Romark Laboratories
Romark Laboratories ( http://www.romark.com ) is a pharmaceutical company dedicated to the discovery and development of innovative new first-in-class and best-in-class pharmaceutical products. Headquartered in Tampa, Florida, Romark conducts research and commercializes its products in the United States and in international markets.
Romark LaboratoriesCONTACT: Melissa Meehan, Hill & Knowlton Public Relations,+1-813-775-6211, for Romark Laboratories
Web site: http://www.romark.com/
