FDA Approves Alinia for Diarrhea Caused by Cryptosporidium Infection

Drug News-- June 16, 2005

FDA Approves First-Ever Treatment for Adults, Teens with Diarrhea Caused by Cryptosporidium Infection

Alinia receives priority review by FDA

TAMPA, Fla., June 16, 2005 -- 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 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.

About Romark Laboratories

Romark Laboratories is a privately owned, research-based pharmaceutical company based in Tampa, Fla., dedicated to the discovery and development of innovative new first-in-class and best-in-class drugs.

About Alinia

Alinia tablets, 500 mg, are indicated for treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum in patients 12 years of age and older. Alinia suspension, 100mg/5mL, is indicated for treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum in patients 1 year of age and older. Alinia tablets are administered as one tablet twice daily for three days. Alinia suspension is administered as 5 mL twice daily for three days for patients 1 through 3 years of age, 10 mL twice daily for three days for patients 4 through 11 years of age, and 25 mL twice daily for three days for patients 12 years of age and older. Alinia has not been shown to be superior to placebo for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients. The most common adverse events reported by patients receiving Alinia have been abdominal pain, diarrhea, headache and nausea. In controlled trials, the frequency of these events has been similar to patients receiving a placebo.

Source: Romark Laboratories

Posted: June 2005


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