FDA panel votes to recommend approval for new pain reliever
Approval limited to osteoarthritis and rheumatoid arthritisDecember 1, 1998
Web posted at: 4:07 p.m. EST (2107 GMT)
SILVER SPRING, Maryland (CNN) -- A new type of pain reliever was recommended for approval as a treatment for osteoarthritis and rheumatoid arthritis by an advisory panel to the U.S. Food and Drug Administration on Tuesday.
Data presented to the panel found the drug alleviates pain without causing serious stomach trouble that can result from many other aspirin-like pain relievers.
Osteoarthritis is associated with aging and affects about 21 million Americans. Rheumatoid arthritis is an autoimmune disorder that affects one in 100 Americans and tends to strike in the prime of life.
The new drug, Celebrex, is the first in a new class of drugs called COX-2 inhibitors to go before the FDA's formal drug approval process.
Current non-steroidal, anti-inflammatory drugs and aspirin can cause ulcers or stomach bleeding, especially when used long-term. It is estimated 100,000 people are hospitalized each year in the United States for this complication and 10,000 to 20,000 people die.
Fifty-one studies including more than 13,000 patients show Celebrex is effective and safe when used for up to two years. No unusual side effects were seen when used to treat acute or chronic pain.
Studies also show Celebrex, made by Searle, can be given once a day to alleviate pain.
COX-2 inhibitors work by blocking an enzyme that triggers pain and inflammation. However, they do not block another enzyme, COX-1, which protects the stomach.
Merck has submitted a similar drug, Vioxx, for FDA approval. Several other COX-2 inhibitors are also under study.
If the FDA follows the recommendation of its advisory panel, Celebrex could be on the market in the spring. The FDA is not bound by advisory panel recommendations but usually follows them.
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