PI Perspective #32

March 2001     View PDF     En español

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).
• 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.