The U.S. Food and Drug Administration (FDA) has approved Alinia (nitazoxanide) tablets and oral suspension for treating diarrhea caused by Cryptosporidium parvum infection in adults and children 12 years and older. The product, already approved to treat the same infection in younger children, received a priority review by FDA.
For adults and teens, FDA's decision brings a first-ever treatment for infections caused by the waterborne protozoan that is recognized as widespread in the United States. Cryptosporidium is reported to be found in 65% to 97% of surface water in the United States and is recognized as the leading cause of waterborne disease outbreaks. Infection is typically spread by person-to- person contact or through contaminated water or food.
"This approval is important," said A. Clinton White, Jr., M.D., a professor of infectious disease at Baylor College of Medicine in Houston, Texas. "Cryptosporidium is a common, yet significantly underdiagnosed, cause of diarrheal illness in the United States."
After being ingested by humans, Cryptosporidium typically causes watery diarrhea with abdominal pain that lasts for one to four weeks or more. Children, the elderly and persons with weak immune systems are particularly susceptible to severe or protracted disease. Traditional antibiotics used to treat gastrointestinal infections are not effective in treating Cryptosporidium.
In a recent study of patients with diarrhea caused by Cryptosporidium, nitazoxanide significantly reduced the duration of diarrhea and other gastrointestinal symptoms compared to a placebo. 96% of patients treated with Alinia tablets and 87% of patients treated with Alinia suspension were well within 7 days after initiating treatment compared to only 41% of patients who received a placebo (sugar pill). The study also showed that Alinia was safe and well-tolerated by patients. All patients in the Alinia treatment groups completed their treatment. Mild adverse events (abdominal pain, headache and nausea) reported by patients receiving Alinia were similar to those reported by patients receiving a placebo.