FDA Okays ‘Super-Aspirin'
Vioxx Meant to Fight Pain Without Side-Effects
N E W Y O R K, May 21 — The U.S. Food and
Drug Administration has given Merck & Co.
approval to market its long-awaited
“super-aspirin” Vioxx to treat pain associated
with osteoarthritis and acute general and
menstrual pain, the pharmaceutical giant said
today.
Vioxx will now compete with Monsanto Co.'s Celebrex,
the first in a new class of revolutionary drugs designed to
battle pain and inflammation without the side effects of
aspirin and related drugs such as ibuprofen, which can
cause deadly internal bleeding.
An estimated 16,000 people a year die from deadly
ulcers caused by conventional painkillers, which block the
COX-1 enzyme that protects the stomach lining.
Similar Pricing to Celebrex
New Jersey-based Merck said Vioxx will cost patients
between $2.38 and $2.52 per tablet, competitive with the
$2.42 price of Celebrex, which was launched in January.
Vioxx is expected to be in pharmacies before mid-June.
Despite Celebrex's head start and robust sales, Merck
has said Vioxx could enjoy a possible marketing advantage
over its rival because it is “a true once-a-day drug.”
Celebrex is taken once or twice a day for osteoarthritis,
the breakdown of joint cartilage from normal wear and tear,
and twice a day for rheumatoid arthritis, an auto-immune
disease caused when the patient's body attacks the joints.
Additional Applications
Celebrex is not approved for acute chronic pain, such as
from dental surgery, which Merck has said could give
Vioxx another marketing edge.
Merck is counting on Vioxx, expected by analysts to be
a multibillion-dollar product within several years, to help the
company overcome the loss of U.S. patent protection on
five of its key drugs by 2001.
Combined 1998 sales from three of those drugs were
more than 25 percent of Merck's drug sales last year.
Merck said the recommended dose for osteoarthritis is
12.5 milligrams daily, with some patients possibly benefiting
from 25 mg daily. For acute pain, the recommended Vioxx
dose is 50 mg once daily.
Use of Vioxx for more than five days has not been
studied.
Like Celebrex, Vioxx will carry a label advising patients
to be alert for ulceration and bleeding that can occur
without warning.
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