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Bristol-Myers Says U.S. OKs New Version of HIV Drug

October 31, 2000
WASHINGTON (Reuters) - Bristol-Myers Squibb Co. (NYSE:BMY - news) said on Tuesday U.S. regulators approved a new version of its anti-HIV drug Videx that can be taken daily as a single pill and has fewer side effects than the older formula.

The Food and Drug Administration cleared the new formula, known as Videx EC, company spokesman John Kouten said. The older formulation required two pills once per day.

Videx is approved for use in combination with other drugs to fight HIV, the virus that causes AIDS . It is the only anti-HIV drug with one-pill-a-day dosing, Kouten said.

The new Videx capsules were formulated without buffers that have been associated with gastrointestinal side effects such as diarrhea, Kouten said.

Company studies showed that fewer patients taking Videx EC experienced diarrhea than those taking the prior version, Kouten said, adding that effectiveness was equal to earlier drug.

Simplifying HIV treatment is important because patients often must take several drugs at different times each day. The complicated regimens sometimes reduce compliance and, therefore, effectiveness. Also, failure to follow drug schedules can allow the virus to grow resistant to treatment.

Videx, first approved in 1991, is part a class of AIDS drugs known as nucleoside analog reverse transcriptase inhibitors. The drugs work by blocking an enzyme the virus uses to reproduce.

Videx is known generically as didanosine or ddI. Worldwide sales last year were $205 million.