New Formulation of ddI Approved

After numerous failed attempts at developing a new formulation of ddI (Videx), Bristol-Myers Squibb has finally secured Food and Drug Administration (FDA) approval for a new version of the drug. The advantages of the new formulation are:

• It can be taken once a day.

• It can be taken at the same time as the protease inhibitors and other commonly used drugs, including indinavir (Crixivan), dapsone, ciprofloxacin (Cipro), and ketoconazole (Nizoral).
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• It can be swallowed rather than chewed or mixed with water.

Unlike the old version, the new formulation does not contain any buffer so the likelihood of diarrhea as a side effect should be reduced. However, the studies using the new formulation did not show a reduction in diarrhea compared to the old version, but this is likely due to the fact that everybody in the study also took nelfinavir, a protease inhibitor that commonly causes diarrhea. The new formulation still has to be taken on an empty stomach, at least 30 minutes before or two hours after eating.

Back to the Project Inform Perspective March 2001 contents page.