Romark Laboratories announced that the US FDA has approved Alinia (nitazoxanide) Tablets for treating diarrhoea caused by Giardia lamblia in patients 12 years of age and older. The Alinia Tablets received a priority review from the FDA.

The FDA also extended the approved uses of Alinia for Oral Suspension to include diarrhoea caused by Giardia lamblia in patients 12 years of age and older. The suspension was approved by FDA late in 2002 for treating children 1 through 11 years of age with diarrhoea caused by Giardia lamblia and Cryptosporidium parvum, another common cause of persistent diarrhoea, a company release said.

Alinia, a first-in-class antiprotozoal drug, is a safe, well-tolerated, short three-day course of treatment that is administered twice daily. The New Drug Applications for Alinia Tablets and Oral Suspension were designated for priority review by the FDA. This classification is reserved for products considered significant improvements compared to currently marketed products in the treatment, diagnosis or prevention of a disease, the release says.

A Clinton White, professor, Infectious Disease, at Baylor College of Medicine, called the development of Alinia "an important advance" in the treatment of diarrhoeal illnesses. "Persistent diarrhoea is a problem for people of any age, but can take an especially heavy toll on the elderly and children, as well as on people with immune deficiencies. This has been a neglected area of drug research," he commented. "Intestinal protozoans are a common cause of persistent diarrhoea and Alinia is an important addition to the physician's arsenal in combating this type of disease," he added.

In placebo-controlled clinical studies in adults, Alinia Tablets and Oral Suspension were 83 to 100 per cent effective in resolving diarrhoea and related symptoms. The adverse events experienced by patients receiving Alinia were not significantly different from those receiving a placebo (sugar pill). The most common adverse events reported, regardless of causality assessment, were abdominal pain (6.7%), diarrhoea (4.3%), headache (3.1%) and nausea (3.1%), the release says.

Alinia for Oral Suspension and Alinia Tablets have not been shown to be superior to placebo for the treatment of diarrhoea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients. The safety and effectiveness of Alinia for Oral Suspension or Alinia Tablets for the treatment of diarrhea caused by Cryptosporidium parvum in patients 12 years of age and older have not been established.

Romark chairman and CSO Jean-François Rossignol, who invented nitazoxanide, said, "Alinia is an ideal alternative to older drugs such as metronidazole. While these other drugs have played a valuable role, they are often associated with concerns regarding safety and tolerability and are less than ideal for managing intestinal infections."

"We are thrilled to reach this significant milestone in furthering the clinical development of Alinia," said Marc Ayers, Romark's president and chief executive officer. "Studies are currently underway to evaluate the impact of Alinia as a treatment in a variety of other gastrointestinal infections so as to extend its benefit to a broader range of patients."

Giardia, the most prevalent intestinal protozoan infection in the US, is a common cause of persistent diarrhoea, a condition defined as diarrhoea lasting more than seven days. The US Centres for Disease Control and Prevention (CDC) estimates there are as many as 2.5 million cases of giardiasis each year. People contract this type of infection from person-to-person contact, day care centres, public water supplies, swimming pools and other recreational water, animals and contaminated foods.