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News (Media Awareness Project) - US: NYT: Painkiller To Get Quick FDA Review
Title:US: NYT: Painkiller To Get Quick FDA Review
Published On:1998-08-24
Source:New York Times (NY)
Fetched On:2008-09-07 02:31:36
PAINKILLER TO GET QUICK FDA REVIEW

NEW YORK (AP) -- A much-anticipated painkiller by Monsanto's G.D. Searle &
Co. unit will get a speedy review by the Food and Drug Administration.

The drug, Celebra, received a priority review for acute and chronic use in
treatment of certain types of arthritis, Monsanto officials said in a
statement Monday.

Priority reviews take about six months, compared with about a year for
those not on the speedy review list. That means the drug could be on the
market by early next year in the United States and late 1999 abroad.

Monsanto has agreed to be acquired by American Home Products, but the St.
Louis-based company's Searle unit had previously signed an agreement to
market Celebra with rival drug maker Pfizer Inc. of New York.

Celebra is the first of a new class of drugs called cox-2 inhibitors to
receive FDA review. The drugs block the inflammatory enzyme cyclooxygenase.
Aspirin and similar anti-inflammatory drugs do that too, but the new drugs
also block the cox-1 enzyme that protects the stomach lining.

Wall Street analysts have ambitious forecasts for the painkiller, with some
estimates suggesting the drug could peak at $4 billion. The current global
market for prescription painkillers, not including over-the-counter sales,
is $5 billion.

Searle isn't the only company working on a cox-2 drug. Merck & Co. is about
six months behind in developing a rival painkiller named Vioxx. Glaxo
Wellcome PLC, Johnson & Johnson and Roche Laboratories also have cox-2
drugs on the way. Merck and Searle are already entangled in a legal battle
over patents.

Having tested Celebra's effects on rheumatoid arthritis, osteoarthritis and
dental pain, scientists are now researching signs that Celebra might help
prevent colon cancer and Alzheimer's disease, in which cox-2 is believed to
play a role.

If the drug is approved for rheumatoid arthritis, the most severe joint
disease, doctors would be free to prescribe it for a number of painful
conditions.

Copyright 1998 The New York Times Company
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