Monday, May 11, 1998
WASHINGTON - The refusal of the FDA's Antiviral Drugs Advisory
Committee to endorse Unimed Inc.'s NDA for Cryptaz nitazoxanide last week may
indicate that the bar for approval of AIDS therapies has been raised from the
early, desperate days of the epidemic when the panel was satisfied with a slight
suggestion of efficacy.
UMED's experience, in which a panel voted 9 to 1 against approval of Cryptaz to treat cryptosporidiosis-induced diarrhea in AIDS patients, also reflects the increasing difficulty in running clinical trials in AIDS-related conditions.