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FDA Approves Nitazoxanide for Treating Diarrhea Caused by <i>Giardia</i>

TAMPA, Fla., July 22 /PRNewswire/ -- Romark Laboratories announced today that the U.S. Food and Drug Administration (FDA) has approved Alinia® (nitazoxanide) Tablets for treating diarrhea 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 diarrhea 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 diarrhea caused by Giardia lamblia and Cryptosporidium parvum, another common cause of persistent diarrhea.

Giardia, the most prevalent intestinal protozoan infection in the U.S., is a common cause of persistent diarrhea, a condition defined as diarrhea lasting more than seven days. The U.S. Centers 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 centers, public water supplies, swimming pools and other recreational water, animals and contaminated foods.

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.

A. Clinton White, M.D., professor of Infectious Disease, at Baylor College of Medicine, called the development of Alinia "an important advance" in the treatment of diarrheal illnesses. "Persistent diarrhea 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 diarrhea and Alinia is an important addition to the physician's arsenal in combating this type of disease."

Performance in Clinical Trials

In placebo-controlled clinical studies in adults, Alinia Tablets and Oral Suspension were 83 to 100 percent effective in resolving diarrhea 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%), diarrhea (4.3%), headache (3.1%) and nausea (3.1%).

Romark Chairman and Chief Science Officer 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."

Alinia 3-Day Therapy Packs™ will be available in pharmacies in September. Each Alinia 3-Day Therapy Pack will contain a full course of therapy for adults and adolescents, 6 Alinia (nitazoxanide) Tablets, 500 mg. Alinia Tablets will also be supplied in bottles of 60 tablets.

Alinia (nitazoxanide) for Oral Suspension, 100 mg/ 5 mL, is already available in pharmacies. The suspension is important for children, and also for adults who may be unable to swallow tablets.

"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."

Ayers noted that the economic burden (lost productivity and medical costs) associated with diarrheal illnesses in the U.S. has been estimated at up to $23 billion per year. There are an estimated 375 million diarrheal illnesses in the U.S. per year, resulting in 73 million physician consultations, 1.8 million hospitalizations and 3,100 deaths.

FDA Approved Indications for Alinia Diarrhea caused by Giardia lamblia:

Alinia for Oral Suspension (patients 1 year of age and older) and Alinia Tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia.

Diarrhea caused by Cryptosporidium parvum:

Alinia for Oral Suspension is indicated for patients 1 through 11 years of age for the treatment of diarrhea caused by Cryptosporidium parvum. Alinia for Oral Suspension and Alinia Tablets have not been shown to be superior to placebo for the treatment of diarrhea 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.For more information on Alinia, visit https://www.alinia.com/.

Source: Romark Laboratories, L.C.

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