TAMPA, Fla. -- Romark Laboratories announced it will donate up to $1 million of its gastrointestinal anti-infective drug, Alinia (nitazoxanide), to public health authorities in the Gulf states affected by Hurricane Katrina. The drug is the only FDA-approved treatment for infectious diarrhea caused by Cryptosporidium.
Cryptosporidium infection is a particular concern for persons affected by the hurricane. Cryptosporidium is reported to be found in 65 percent to 97 percent of surface water and is recognized as the leading cause of waterborne disease outbreaks in the United States.
Marc Ayers, president and chief executive officer for Romark, said it is important that Alinia get to those people who are impacted by the lack of treated water or are around the polluted water that has flooded many of the communities along the northern Gulf coast. "We are making supplies available to relief agencies and public health authorities in these states as soon as they are ready to receive them," Ayers added.
The donations of Alinia will include a liquid suspension for children and tablets for teens and adults. Alinia is approved for use in children down to 12 months of age.
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 diseases. Traditional antibiotics used to treat gastrointestinal infections are not effective in treating Cryptosporidium.
Alinia is the first drug ever proven effective in treating diarrhea caused by Cryptosporidium. It received a priority review by FDA and was first approved for use in children in November 2002, then for treating Cryptosporidium in teens and adults in June of this year.
Alinia is also approved by the FDA for treating infectious diarrhea caused by Giardia lamblia, another common intestinal infection that is likely to become a more significant problem in the areas affected by Hurricane Katrina.
About Romark Laboratories
Romark Laboratories is a pharmaceutical company dedicated to the discovery, development and commercialization of innovative new first-in-class and best-in-class pharmaceutical products.
About Alinia
Alinia (nitazoxanide) is indicated in the United States for treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum in patients 1 year 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. Alinia is under development in the United States for treatment of Clostridium difficile-associated diarrhea and Crohn's disease.
Source: Romark Laboratories