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