Cryptosporidium parvum treatment approved

July 2005

The FDA has approved nitazoxanide (Alinia, Romark) tablets and oral suspension for treating diarrhea caused by Cryptosporidium parvum infection in adults and children 12 and older.

The product, already approved in younger children, received a priority review by the FDA.

For adults and teenagers, the FDA’s decision brings the first treatment for infections caused by the waterborne protozoan that is recognized as widespread in the United States.

“This approval is very important,” said A. Clinton White, Jr., MD, professor of infectious diseases, Baylor College of Medicine, Houston, in a press release. “Cryptosporidium is a common, yet significantly underdiagnosed, cause of diarrheal illness in the United States.”

About the drug

In a recent study of patients with diarrhea caused by Cryptosporidium, nitazoxanide significantly reduced the duration of diarrhea and other gastrointestinal symptoms compared with placebo. Ninety-six percent of patients treated with nitazoxanide tablets and 87% of patients treated with nitazoxanide suspension were well within seven days after initiating treatment compared with only 41% of patients who received a placebo. The study also showed that nitazoxanide was safe and well tolerated by patients.

All patients in the nitazoxanide treatment groups completed their treatment. Mild adverse events, such as abdominal pain, headache and nausea reported by patients receiving nitazoxanide were similar to those reported by patients receiving a placebo.

This approval is the third for the drug in the last 31 months. It is available as a tablet or a strawberry liquid to be taken orally twice daily for three days.