FDA APPROVES VIOXX(R) (ROFECOXIB), A NEW MEDICINE FROM MERCK
Vioxx is Approved for Osteoarthritis, Acute Pain in Adults and Menstrual Pain
WEST POINT, Pa., May 21 /PRNewswire/ -- Merck & Co., Inc. announced today that the Company's new once-a-day medicine Vioxx(R) (rofecoxib) has received marketing approval from the U.S. Food and Drug Administration. Vioxx has been approved for relief of the signs and symptoms of osteoarthritis (OA), management of acute pain in adults, and treatment of menstrual pain (primary dysmenorrhea).
Vioxx was evaluated for the treatment of the signs and symptoms of OA in placebo- and active-controlled clinical trials of six to 86 weeks that included approximately 3,900 patients. The effectiveness of Vioxx 12.5 mg and 25 mg once a day was shown to be comparable to prescription-strength non- steroidal, anti-inflammatory drugs (NSAIDs) ibuprofen 800 mg three times a day and diclofenac 50 mg three times a day for treatment of the signs and symptoms of OA. The ibuprofen studies were six-week studies; the diclofenac studies were 12-month studies in which patients could receive additional arthritis medication during the last six months. In all OA clinical studies, once-daily treatment in the morning with Vioxx 12.5 mg and 25 mg was associated with a significant reduction in joint stiffness upon first awakening in the morning.
Furthermore, in two six-month studies of OA patients, treatment with Vioxx 25 mg daily or 50 mg daily was associated with a significantly lower percentage of patients with gastroduodenal ulcers, as detected by an endoscope, than treatment with ibuprofen 2,400 mg daily. An endoscope is an instrument designed to look inside the stomach. The correlation between findings of endoscopic studies, and the relative incidence of clinically serious upper gastrointestinal (GI) events that may be observed with different products, has not been fully established. Serious clinically significant upper GI bleeding has been observed in patients receiving Vioxx in controlled trials, albeit infrequently. Prospective, long-term studies required to compare the incidence of serious, clinically significant upper GI adverse events in patients taking Vioxx versus comparator NSAID products have not been performed.
In studies of post-operative dental pain, post-orthopedic surgical pain, and primary dysmenorrhea, Vioxx relieved pain that was rated by patients as moderate to severe. Studies lasted up to five days. The analgesic effect (including onset of action) of a single 50 mg dose of Vioxx was generally similar to naproxen sodium 550 mg or ibuprofen 400 mg.
Selected Cautionary Information
The most common side effects reported in clinical trials with
Vioxx were upper-respiratory infection, diarrhea and nausea. People
who have had an allergic reaction to Vioxx, aspirin or other
traditional NSAIDs should not take Vioxx.
Although Vioxx has a low potential for stomach ulcers, serious GI ulcers can occur without warning symptoms. Physicians and patients should remain alert for signs and symptoms of GI bleeding. Vioxx should not be taken by women in late pregnancy. Safety and effectiveness in children have not been evaluated.
Dosing Information
The recommended dose for OA is 12.5 mg once daily. Some patients
may receive additional benefit by increasing the dose to 25 mg once
daily. For acute pain, the recommended dose is Vioxx 50 mg once daily.
Use of Vioxx for more than five days for the management of pain has not
been studied.
How Vioxx Works
At recommended doses, scientists believe Vioxx blocks the enzyme
that triggers pain and inflammation (COX-2), while sparing a related
enzyme that helps maintain the normal stomach lining (COX-1). In
general, traditional NSAIDs block both enzymes. They treat pain and
inflammation, but may damage the stomach lining, potentially leading to
ulcers in some patients.
Osteoarthritis
Osteoarthritis is the most common form of arthritis and a leading
cause of disability and nursing home admission in the United States.
It is a progressive, degenerative joint disease in which the cartilage
covering the ends of the bones deteriorates, causing varying degrees of
pain, inflammation and disability.
Vioxx to be in Pharmacies Before Mid-June
Vioxx, which underwent a priority review by the FDA, should be
available in pharmacies beginning the second week of June.
Merck's catalog price to wholesalers and direct purchasers for both Vioxx 12.5 mg tablets and Vioxx 25 mg tablets will be $2.02 per tablet. (For estimated retail prices, see note below.)
Merck's catalog price per dose for the liquid formulation of Vioxx will be $3.00 for Vioxx 12.5 mg/5 mL and $3.00 for Vioxx 25 mg/5 mL.
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 our
joint ventures, and provides pharmaceutical benefit services through
Merck-Medco Managed Care.
Vioxx(R) is the Merck registered trademark for rofecoxib.
CONTACT: Jan Weiner, media, 215-652-6462, or Laura Jordan, investors,
908-423-5185, both of Merck & Co.
SOURCE Merck & Co., Inc.
--------------------------------------------------------------------------------
05/21
|
