VIOXX

Subject: Phase II Studies Showed Vioxx(TM) Merck's COX-2 Specific...
Date: Mon, 20 Apr 1998 16:18:24 EDT
From: AOL News <AOLNews@aol.com>
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Phase II Studies Showed Vioxx(TM) Merck's COX-2 Specific Inhibitor, Relieved
the Symptoms of Arthritis and Pain 

Endoscopy Study With Vioxx Showed Gastrointestinal Safety Profile 

Similar to Placebo 

 SAN FRANCISCO, April 20 /PRNewswire/ -- Results from five dose-ranging
studies with Merck's once daily, COX-2 specific inhibitor, Vioxx(TM), showed
that it relieved the symptoms of osteo- and rheumatoid arthritis and the
pain associated with dental surgery and menstrual cramps.  In addition, a
separate endoscopy study showed that Vioxx was well-tolerated with no serious
gastrointestinal (GI) side effects reported -- even at doses ten times higher
than clinical doses being studied in Merck's ongoing Phase III trials. Larger
studies with the investigational medication are underway to confirm these
findings.  The data were presented today at a scientific symposium sponsored
by the American Society for Pharmacology and Experimental Therapeutics at
the Experimental Biology '98 conference. 

Vioxx is in a new class of medicines called COX-2 specific inhibitors, that
work by inhibiting an enzyme (cyclooxygenase-2) that is responsible for
producing pain and inflammation without affecting cyclooxygenase-1 (COX-1),
an enzyme that primarily protects the stomach lining.  The inhibition of COX-1
is believed to be the cause of serious GI side effects, such as stomach
perforations, ulcers and bleeds.  These side effects have been associated
with the use of NSAIDs, or non-steroidal anti-inflammatory drugs, and have
reportedly resulted in more than 76,000 hospitalizations and 7,600 deaths
each year in the United States (J. Rheumatol. 18 (suppl. 28), 1991).  NSAIDs
inhibit both COX-1 and COX-2, and are the most common treatment used today for
acute and chronic pain and inflammatory conditions, such as arthritis. 

"These studies demonstrated that Vioxx is specific for COX-2 and that it has
effectively relieved pain and inflammation across a wide range of doses,"
said Alan Nies, M.D., vice president of clinical sciences, Merck Research
Laboratories, who presented the results.  "Even at doses ten times higher
than the dose being used in our Phase III studies, Vioxx has shown
gastrointestinal safety similar to placebo in our endoscopy study," Dr. Nies pointed out. 

Study results presented today showed: 

--  Vioxx improved physical functioning and reduced pain and inflammation
in nearly three times more patients with osteoarthritis of the knee
and hip than did treatment with placebo.  Vioxx was also shown to be
generally well-tolerated with no serious GI side effects reported.
The most commonly reported side effects for both Vioxx and placebo in
this study were diarrhea, headache, insomnia, edema and upper
respiratory infection.  These results were presented at the 1997
American College of Rheumatology. 

--  Vioxx reduced pain and inflammation in patients with rheumatoid
arthritis in a six-week pilot study.  Additional findings from the
study will be presented later this year. 

--  Vioxx relieved post-surgery dental pain as effectively as naproxen
sodium and ibuprofen, two NSAIDs commonly used to relieve moderate to
severe pain.  Results are from two separate dental pain studies that
were previously presented at the 1998 Clinical Pharmacology and
Therapeutics meeting and the 1996 American College of Rheumatology. 

--  Vioxx produced greater relief of menstrual pain when compared to
ibuprofen and placebo.  Additional findings from the study will be
presented later this year. 

--  The GI safety profile of Vioxx -- even at doses ten times higher than
the clinical doses now being studied in Merck's larger studies -- was
comparable to placebo based on the results of a seven-day endoscopy
study of healthy volunteers.  The study was previously presented at
the 1997 American Gastroenterology Association. 

About Vioxx
Vioxx is being evaluated in Phase III studies looking at clinical efficacy
and safety in a broad patient population suffering from osteoarthritis and other
painful conditions.  Additional studies of Vioxx in patients with rheumatoid
arthritis, Alzheimer's disease and colon cancer are or soon will be
underway. 

Treatment with Vioxx has been generally well-tolerated across all studied
doses.  The most commonly reported side effects were diarrhea, headache,
insomnia, edema and upper respiratory infection.  These side effects were
transient and did not cause patients to discontinue from the studies. Merck
will begin worldwide regulatory filings by the end of 1998. 

Merck & Co., Inc. (NYSE: MRK) is a leading research-driven pharmaceutical
products and services company.  Merck discovers, develops, manufactures and
markets a broad range of innovative products to improve human health. 

SOURCE  Merck & Co., Inc.
CO:  Merck & Co., Inc.
ST:  Pennsylvania, California
IN:  MTC
SU:  PDT 

04/20/98 16:13 EDT http://www.prnewswire.com