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FDA Approves Treatment for Diarrhea Caused by Cryptosporidium Infection
“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.”
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-François 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.
Source: Romark Laboratories