11/23 18:00 Merck Submits New Drug Application for Vioxx(TM), An Investigational <MRK.N>
Merck Submits New Drug Application for Vioxx(TM),
An Investigational COX-2 Specific Inhibitor
WEST POINT, Pa., Nov. 23 /PRNewswire/ -- Merck & Co., Inc. (NYSE: MRK)
today announced it has submitted to the U.S. Food and Drug Administration
(FDA) a New Drug Application for Vioxx(TM) (rofecoxib), an investigational
once-daily, anti-inflammatory COX-2 specific inhibitor for the treatment of
osteoarthritis and pain. COX-2 specific inhibitors are being studied to
determine whether the apparent difference in how they work may result in fewer
certain serious gastrointestinal side effects than nonsteroidal
anti-inflammatory drugs, which are medications that are currently available
for the treatment of osteoarthritis and pain.
Merck's application includes results from 68 studies in nearly
10,000 patients that evaluated Vioxx for the treatment of the signs and
symptoms of osteoarthritis and for the relief of pain. Within the next
60 days, the FDA will determine whether or not it will accept Merck's
application as submitted. Merck expects to begin to file similar regulatory
applications for Vioxx, worldwide, by the end of the year.
Merck scientists have contributed to many important scientific discoveries
in the treatment of pain and inflammation of arthritis over the past sixty
years.
Merck & Co., Inc. is a global research-driven pharmaceutical company that
discovers, develops, manufactures and markets a broad range of human and
animal health products, directly and through its joint ventures, and provides
pharmaceutical benefit services through Merck-Medco Managed Care.
Vioxx(TM) is the Merck trademark for rofecoxib.
SOURCE Merck & Co., Inc.
-0- 11/23/98
/CONTACT: Media, Kyra Lindemann, 215-652-6931, or Investor, Laura Jordan,
908-423-5185, both for Merck/
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