FDA Grants Priority Review for Vioxx(TM) Merck's Investigational Medicine for Osteoarthritis and Pain
WEST POINT, Pa., Jan. 11 /PRNewswire/ -- Merck & Co., Inc. (NYSE: MRK) announced today that the U.S. Food and Drug Administration has assigned a six-month priority review to the Company's New Drug Application for Vioxx(TM) (rofecoxib), an investigational COX-2 specific inhibitor for osteoarthritis and pain. Merck submitted the application for Vioxx on Nov. 23, 1998.
Merck's application for Vioxx includes results from 68 studies involving nearly 10,000 patients. Those studies evaluated the safety and efficacy of the once-daily, anti-inflammatory medicine for the treatment of the signs and symptoms of osteoarthritis and for the relief of pain.
COX-2 specific inhibitors are being studied to determine whether the apparent differences 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 & 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.
SOURCE Merck & Co., Inc. |
