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.
Earlier studies showed that Alinia suspension is effective in reducing the duration of diarrhea and other gastrointestinal symptoms caused by Cryptosporidium in pediatric outpatients aged 1 through 11 years and in pediatric inpatients aged 12 to 35 months who were immunocompromised due to severe malnutrition.
"In addition to safety and tolerability demonstrated in clinical trials, the effectiveness of Alinia in treating a difficult infection like Cryptosporidium clearly sets it apart from any other drug," said Jean-Francois Rossignol, M.D., Ph.D., chairman and chief science officer of Romark.
The approval granted by FDA is the third approval of a New Drug Application for Alinia within the past 31 months. Alinia is now indicated for treatment of diarrhea caused by Giardia or Cryptosporidium in patients 1 year of age and older. It is available as a tablet or a strawberry-flavored liquid to be taken orally twice daily for three days. Romark is continuing to conduct research to determine Alinia's effectiveness in treating other important gastrointestinal diseases including Clostridium difficile-associated diarrhea and Crohn's disease.