11/10 19:38 Merck says new drug Vioxx effective in arthritis
By Mark Egan
LOS ANGELES, Nov. 10 (Reuters) - A new drug designed to compete with
popular anti-inflammatory pills like Motrin and aspirin, is effective in treating the
most common and severe forms of arthritis, researchers said on Tuesday.
Researchers said phase III trials of Vioxx, known generically as rofecoxib,
showed it was equally effective in relieving pain and inflammation in patients
with osteoarthritis as the most commonly prescribed drugs currently available.
Phase III trials are typically the last stage before seeking regulatory approval for
a drug.
Osteoarthritis is the most common form of arthritis affecting about 20 million
Americans. It is caused by the wearing down of cartilage in the joints and often
results in patients needing hip or knee replacement surgery.
The two trials compared Vioxx with high doses of diclofenac, which is
marketed as Voltaren, and ibuprofen, which is marketed as Advil and Motrin,
and found the new drug to be as effective in treating pain and improving joint
functions.
Vioxx, made by Merck & Co. <MRK.N> is part of a new class of drugs
knows as Cox-2 inhibitors. The drug fights pain and inflammation by blocking
the so-called Cox-2 enzyme.
Commonly available drugs such as Motrin, aspirin and Voltaren also work by
inhibiting the Cox-2 enzyme, but often cause ulcers and other gastrointestinal
side effects by also blocking the Cox-1 enzyme which protects the stomach
lining.
"When we looked at Vioxx's effectiveness compared to the most commonly
used drugs available it was equally effective," Dr. Michael Franklin, chief of
rheumatology at the Abington Memorial Hospital, Philadelphia, and a lead
investigator in the trials -- paid for my Merck -- told Reuters.
"The bottom line that we hope to show is that we can have equal effectiveness
with significantly decreased side effects like ulcers, bleeding and other stomach
problems," he said.
Franklin said about 76,000 people are admitted to hospitals annually as a result
of side effects from anti-inflammatory drugs with about 7,600 deaths each year
attributed to the drugs. He said those problems could be largely eradicated with
the use of Cox-2 inhibitors.
A separate phase II trail of Vioxx found it to be effective in treating rheumatoid
arthritis, the most severe form of the disease. Rheumatoid arthritis affects 2.5
million Americans and can cripple patients as the joints are destroyed.
The rheumatoid arthritis trial showed that twice as many patients taking the drug
compared to those taking a placebo reported an easing of symptoms and pain.
Results of the trials were presented at the American College of Rheumatology's
annual meeting in San Diego.
Merck plans to file for regulatory approval of Vioxx as a treatment for
osteoarthritis later this year. Another company, Monsanto Co.'s <MTC.N>
G.D. Searle drug unit, will present data on a competing Cox-2 inhibitor called
Celebra at the meeting later this week. |
