Romark Laboratories announced that the United States Food and Drug Administration (FDA) has approved Alinia (nitazoxanide) for Oral Suspension for treatment of children with diarrhea caused by Cryptosporidium parvum and Giardia lamblia. Alinia is the first and only drug approved by FDA for treatment of Cryptosporidium, and the first new drug approved for Giardia in more than 40 years. The product will be available in pharmacies in February, 2003.

Cryptosporidium and Giardia, the two most common waterborne protozoa in the United States, are common causes of persistent diarrhea among both children and adults. Outbreaks of these organisms have been associated with day care centers, swimming pools, water park wave pools and public water supplies. The approval of Alinia comes on the heels of a newly released study from the Centers for Disease Control and Prevention (CDC) indicating that outbreaks of waterborne illnesses roughly doubled in the United States in a three-year period ending in 2000.

"This drug will have a significant impact on children's health," said Myron Levin, chief of Pediatric Infectious Diseases at the University of Colorado School of Medicine. "Up until now, the treatment options for children who become infected with these organisms have been poor. For Cryptosporidium, there has been no effective drug at all, and for Giardia, existing drugs are either unavailable in a form suitable for children, have an unpleasant taste, or must be taken for up to 10 days."

Alinia for Oral Suspension (100 mg/5mL) will be available in a pleasant-tasting, easy-to-use liquid suspension form. A short, three-day treatment has been approved by the FDA for treating diarrhea caused by Cryptosporidium and Giardia in children aged 12 months to 11 years.

In clinical trials, Alinia significantly reduced the duration of diarrhea caused by Cryptosporidium and Giardia infections. In a study published last month in the British medical journal The Lancet, the drug reduced the duration of diarrhea and also the rate of death of malnourished children in Africa with Cryptosporidium infection.

"This new drug holds great promise for improving the health of children, here in the U.S. and around the world," said A. Clinton White, associate professor, Infectious Disease, at Baylor College of Medicine. "Infections by Cryptosporidium and Giardia take an especially heavy toll on children because they cause diarrhea that is persistent, often lasting for several weeks. Studies in children in developing countries have shown that these infections are associated with malnutrition, impaired growth and development and even death."

According to Jean-Francois Rossignol, Romark's chairman and chief science officer, the drug's unique mechanism of action is important to its safety and efficacy. "Alinia is believed to interfere with enzyme reactions that are essential for anaerobic energy metabolism," he noted. "With this mechanism, the drug is active against both Cryptosporidium and Giardia, and safe for humans."

In placebo-controlled clinical studies, the side-effects experienced for children receiving Alinia were not significantly different from those receiving a placebo (sugar pill). The most common adverse events reported for children were abdominal pain, diarrhea, vomiting and headache. Safety and effectiveness of Alinia have not been studied in children less than 12 months of age or greater than 11 years of age, or in adults. In addition, safety and effectiveness have not been established in patients with immune deficiencies such as patients with human immunodeficiency virus (HIV).

Romark has applications pending with the FDA for approval of nitazoxanide in tablet form for adults, and for treatment of Cryptosporidium-induced diarrhea in AIDS patients. Cryptosporidium infection can be life-threatening in persons with weak immune systems, including those with AIDS, and patients undergoing chemotherapy.

Romark currently markets nitazoxanide in most of Latin America, where it is the fastest-growing product in its class. "Securing this initial FDA approval will be an impetus to expanding awareness of this drug and its benefits in combating diarrheal disease here in the U.S. as well as globally," said Marc S. Ayers, Romark's president and chief executive officer.

Protozoal diarrhea, such as that caused by Cryptosporidium and Giardia, is an important health concern because it is often persistent, lasting for several weeks. Overall, diarrheal illnesses are the second leading cause of morbidity and mortality worldwide, affecting more than one billion people annually. In the U.S., up to 375 million episodes of diarrheal illness occur each year, resulting in 73 million physician consultations, 1.8 million hospitalizations, and 3,100 deaths. The cost of medical care and lost productivity associated with infectious diarrheal illnesses in the U.S. is estimated at more than $20 billion annually.