NTZ Submitted to FDA for Cryptosporidiosis

On January 15 UNIMED Pharmaceuticals announced that it had applied to the FDA for permission to market NTZ (tm) (nitazoxanide) for treating cryptosporidial diarrhea in people with AIDS. The company, which submitted the NDA (new drug application) on December 30, asked for a rapid review, and expects that an FDA advisory committee will consider the drug around May of this year. NTZ is already approved in Mexico.

UNIMED submitted data on over 200 patients in three open-label trials it has conducted, and claims that about 60% of the volunteers improved, with 35 to 45% of them having a greater than 50% reduction in stool volume; these results have not yet been published. A placebo-controlled trial in the ACTG (AIDS Clinical Trials Group of the U.S. National Institute of Allergy and Infectious Diseases) is still recruiting; this trial assigns placebo to half the patients for three weeks, then gives everyone the drug. UNIMED will continue to support this study after drug approval.


Comment

AIDS Treatment News has covered NTZ since January 1996 (see issues

#239, #250, #258, and #260). To us it has long been clear that, barring any major unexpected safety problem, it should be available. But difficulties in trial recruitment, and technical problems such as diagnosing the parasite in some cases, make it hard to get the kind of clean data that appeals to academics and regulators.

NTZ is a very broad spectrum drug, active against many parasites and bacteria. This is important because it is often hard to identify the specific cause for AIDS diarrhea. Exact diagnosis becomes less critical if the drug is active against more than one microbial cause.

UNIMED has found only a few complete cures of cryptosporidiosis after NTZ treatment. But the first person we knew who used the drug has been cured. He is a physician and had complete flexibility to adjust his dose when necessary, as he was not following a research protocol.

Cryptosporidiosis occurs mostly in the summer, often after heavy rains wash cow manure into municipal water supplies, or from swimming in contaminated pools or lakes. Person to person spread is also very important.

The PWA Health Group, the oldest AIDS buyers' club in New York, is still carrying NTZ.