FDA approves diarrhea drug

For adults and teens, the FDA’s decision brings a first-ever treatment for infections caused by the waterborne protozoan that is recognized as widespread in the US. Cryptosporidium is reported to be found in 65% to 97% of surface water in the US 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.

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, Alinia (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 seven days after initiating treatment compared to only 41% of patients who received a placebo (sugar pill).

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 one through 11 years and in pediatric inpatients aged 12 to 35 months who were immunocompromised due to severe malnutrition.

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 one year of age and older.