IDEXX gets FDA nod for EPM treatment

IDEXX Laboratories, Inc. has been approved by the U.S. Food and Drug Administration (FDA) to market and sell NavigatorӨ (32 percent nitazoxanide) antiprotozoal oral paste treatment for equine protozoal myeloencephalitis (EPM).Sarcocystic neurona, the protozoan parasite that causes EPM, is widespread among the equine population, with recent epidemiological surveys estimating approximately 50 percent of all horses in the U.S. have been exposed to the degenerative disease of the central nervous system, IDEXX reports.Navigator paste is a powerful new treatment for this potentially devastating disease, says IDEXX President and CEO Jonathan Ayers. Navigator is a significant component of our strategy to provide innovative diagnostic and therapeutic solutions to equine veterinarians. Navigator paste, part of a new class of drugs (pyruvate:ferredoxin oxidoreductase inhibitors) that block an enzyme essential for energy production in the parasite, successfully treated 81 percent of horses in a field study of more than 400 horses, IDEXX reports. In the same study, 78 percent of horses that had been previously treated unsuccessfully for EPM were successfully treated with Navigator paste. The product, given once daily for 28 days, is formulated in an easy-to-dose, apple-flavored paste. It is packaged in a dispensing box of 26 syringes along with a weight tape and treatment diary.IDEXX advises that horses receiving Navigator paste should be carefully monitored during treatment for adverse reactions. Administration of nitazoxanide can disrupt normal microbial flora of the gastrointestinal tract and lead to enterocolitis, and in some cases, death, the company adds. When treating with Navigator paste, IDEXX recommends obtaining an accurate body weight and calculating the dose weekly. For dosing instructions, refer to the dosing and administration and precautions sections of the package insert, as well as the adverse reactions section of the insert.

For fastest response call (800) 374-8006 or visit the Web site at www.idexx.com/navigator .