Romark's commitment to research is deeply rooted in a tradition of drug discovery and development tied closely to its founder, Jean-François Rossignol. Dr. Rossignol, a Sorbonne graduate, was trained as a chemist and physician, leading to an accomplished career in translational research and drug development.
In 1993, Rossignol and investor/partner Marc Ayers co-founded Romark Laboratories, L.C., to develop Rossignol's invention, nitazoxanide, as a treatment for Cryptosporidium infection and to discover and develop other new small molecule drugs in the same class called the thiazolides.
In 2002, Alinia® (nitazoxanide) suspension was approved by the FDA for treating diarrhea caused by Cryptosporidium parvum and Giardia lamblia in children. Alinia® tablets were approved by the FDA in July 2004.
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 or Cryptosporidium parvum. Alinia for Oral Suspension and Alinia Tablets have not been shown to be superior to placebo for treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.
During 2005 and 2006, Romark's drug discovery program led to the characterization of a new class of drugs called the thiazolides and identification of new drug candidates for treating a broad range of viral diseases.
In 2006, a clinical trial of nitazoxanide, the first thiazolide, in the treatment of severe rotavirus diarrhea was published in The Lancet. This was the first report of clinical efficacy of a thiazolide in treating viral diseases.
In 2008 and 2009, the first clinical trials of nitazoxanide administered alone or in combination peginterferon or peginterferon plus ribavirin in patients with genotype 4 chronic hepatitis C were reported in Alimentary Pharmacology & Therapeutics and Gastroenterology.
In 2009, Rossignol and colleagues reported in the Journal of Biological Chemistry that nitazoxanide and other thiazolides are active against influenza viruses including H1N1 and H5N9 (a low pathogenicity avian strain) by a novel mechanism: targeting the maturation and intracellular transport of the viral hemagglutinin.
In 2010, the first clinical trial of nitazoxanide in patients with influenza was initiated in the United States.
Important Safety Information for Alinia
- Alinia Tablets and Alinia for Oral Suspension are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.
- The pharmacokinetics of nitazoxanide in patients with compromised renal or hepatic function have not been studied. Therefore, nitazoxanide must be administered with caution to patients with hepatic and biliary disease, to patients with renal disease and to patients with combined renal and hepatic disease.
- Tizoxanide is highly bound to plasma protein (>99.9%). Therefore, caution should be used when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (e.g. warfarin).
- It is not known whether nitazoxanide is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nitazoxanide is administered to a nursing woman.
- In clinical studies involving HIV-uninfected patients age 12 years and older receiving Alinia Tablets, the most common adverse events reported regardless of causality assessment were abdominal pain (6.6%), diarrhea (4.2%), headache (3.1%) and nausea (3.0%). In placebo-controlled clinical trials using the recommended dose, the rates of occurrence of these events did not differ significantly from those of the placebo.
- In clinical studies involving HIV-uninfected pediatric patients receiving Alinia for Oral Suspension, the most common adverse events reported regardless of causality assessment were abdominal pain (7.8%), diarrhea (2.1%), vomiting (1.1%) and headache (1.1%). These were typically mild and transient in nature. In placebo-controlled clinical trials using the recommended dose, the rates of occurrence of these events did not differ significantly from those of the placebo.
Selected peer-reviewed publications on investigational products:
DISCLAIMER: This information concerns a use that has not been approved or cleared by the FDA.
- Amadi, B, Mwiya, M, Musuku, J, Watuka, A, Sianongo, S, Ayoub, A & Kelly, P. Effect of nitazoxanide on morbidity and mortality in Zambian children with cryptosporidiosis: a randomised controlled trial. Lancet. 2002;360:1375-1380. Rossignol, JF, Kabil, SM, Said, M, Samir, H, Younis, A. Effect of Nitazoxanide in persistent diarrhea and enteritis associated with Blastocystis hominis. Clinical Gastroenterology & Hepatology. 2005;3:987-991.
- Rossignol, JF, Abou Zekry, M, Hussein, A & Santoro, MG. Effect of nitazoxanide in treating rotavirus diarrhea: a randomized, double-blind, placebo-controlled trial. Lancet. 2006;368:124-29.
- Rossignol, JF, El-Gohary, Yehia M. Nitazoxanide in treatment of viral gastroenteris: a randomized, double-blind, placebo-controlled clinical trial. Alimentary Pharmacology & Therapeutics. 2006;24:1423-30.
- Musher, DM, Logan, N, Hamill, RJ, DuPont, HL, Lentnek, A, Gupta, A & Rossignol, JF. Nitazoxanide in the treatment of Clostridium difficile-associated diseases. Clinical Infectious Diseases. 2006;43:421-7.
- Musher DM, Logan N, Bressler AM, Johnson DP, Rossignol JF. Nitazoxanide versus vancomycin in Clostridium difficile infection: A randomized, double-blind study. Clin Infect Dis 2009;48:e41-e46.v
- Rossignol JF, Kabil SM, El-Gohary Y, Elfert A, Keeffe EB. Clinical trial: randomized, double-blind, placebo-controlled study of nitazoxanide monotherapy for the treatment of patients with chronic hepatitis C genotype 4. Aliment Pharmacol Ther 2008;28:574-580.
- Rossignol JF, Elfert A, El-Gohary Y, Keeffe EB. Improved virologic response in patients with chronic hepatitis C genotype 4 treated with nitazoxanide plus peginterferon alfa-2a with or without ribavirin. Gastroenterology 2009;136:856-862. Rossignol JF, Elfert A, Keeffe EB. Treatment of chronic hepatitis C using a 4-week lead-in with nitazoxanide before peginterferon plus nitazoxanide. J Clin Gastroenterol 2009;Epub ahead of print
- Elazar M, Liu M, McKenna SA, Liu P, Gehrig EA, Puglisi JD, Rossignol J-F, Glenn JS. The anti-hepatitis C agent nitazoxanide induces phosphorylation of elF2a via PKR activation. Gastroenterology 2009;137:1827-1835.