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FASEB MEETING: Vioxx Relieves Dental, Menstrual And Arthritis Pain SAN FRANCISCO, CA -- April 21, 1998 -- Results from five dose-ranging studies with Merck & Co., Inc.’s once-daily, COX-2 specific inhibitor, Vioxx(TM), show that it relieves 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 10 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 yesterday at Federation of the American Society of Experimental Biology 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 non-steroidal anti-inflammatory drugs (NSAIDs) and have reportedly resulted in more than 76,000 hospitalisations and 7,600 deaths each year in the United States. 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 10 times higher than the dose being used in our Phase III studies, Vioxx has shown gastrointestinal safety similar to placebo in our endoscopy study." 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. -- 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. -- Vioxx produced greater relief of menstrual pain when compared to ibuprofen and placebo. -- The GI safety profile of Vioxx, even at doses 10 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. 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 world-wide regulatory filings by the end of 1998. More information on: Merck. E-mail this page to a friend or colleague! To print, use this version