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FDA Approves Vioxx (Rofecoxib) for Once-Daily Treatment of Juvenile Rheumatoid Arthritis

First and Only COX-2 Specific Inhibitor Approved for Use in Children as Young as Two

WHITEHOUSE STATION, NJ -- September 8, 2004 -- Physicians and parents of children afflicted with juvenile rheumatoid arthritis (JRA) -- a debilitating type of arthritis that can occur in toddlers to teenagers -- now have a new choice for symptom relief. Vioxx® (rofecoxib), Merck & Co. Inc.'s once-daily arthritis and pain medicine, received approval from the U.S. Food and Drug Administration (FDA) for the relief of the signs and symptoms of the most common forms of JRA (pauciarticular or polyarticular) in children two years and older and who weigh at least 22 pounds. Vioxx is now the first and only COX-2 specific inhibitor approved for the treatment of JRA, based on clinical research that established safety and effectiveness in children as young as two years of age and who weigh at least 22 pounds.

"As a pediatric rheumatologist, my immediate goal in treating a child or adolescent with JRA is to reduce inflammation or swelling of their joints and to relieve any associated pain," said clinical investigator Elizabeth Candell Chalom, M.D., director of Pediatric Rheumatology, Saint Barnabas Pediatric Subspecialty Center in Livingston, N.J. "With the approval of Vioxx for JRA, we now have a new treatment option that has been shown to be effective in relieving joint symptoms. It offers the convenience of once-daily dosing and is available in a tablet and a strawberry-flavored liquid formulation."

The approval of Vioxx for the relief of the signs and symptoms of JRA follows the recent approval of Vioxx in March for the acute treatment of migraine in adults. Vioxx now has more approved indications than any other COX-2 specific inhibitor. The new indication for JRA further expands the eligible patient population for Vioxx; in addition to the newer indications to treat JRA and migraine pain, Vioxx also is approved for the relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis in adults, management of acute pain in adults and the treatment of primary dysmenorrhea. Since the introduction of Vioxx, over 100 million prescriptions have been written in the United States.(1)

JRA - most common form of arthritis in children
Juvenile rheumatoid arthritis is the most common form of arthritis in children and affects an estimated 30,000 to 50,000 children in the United States.(2) It can occur in children of any age, but girls are more likely to be affected than boys. In March, Merck was granted orphan drug designation for Vioxx for the treatment of JRA, a designation given to medicines that have been researched for the treatment of medical conditions that affect 200,000 people or less in the United States.

Juvenile rheumatoid arthritis is known to cause persistent joint inflammation and stiffness that can affect any joint in the body. There are three major types of JRA: pauciarticular, which affects four or fewer joints; polyarticular, which affects five or more joints; and systemic onset, which affects at least one joint but also causes inflammation of internal organs. The new indication for Vioxx for JRA is only for patients with pauciarticular or polyarticular JRA.

Approval based on largest JRA study ever conducted
The FDA approval of Vioxx for JRA was based on the largest JRA study ever conducted, which included 310 pediatric and adolescent patients aged two to 17 with active pauciarticular or polyarticular JRA. Results from the pivotal 12-week multi-national, double-blind study showed once-daily Vioxx provided measurable improvement in reducing joint symptoms. Improvement was evaluated based on JRA DOI 30 criterion, a core set of standardized criteria to measure arthritis impact. A one-year open-label extension to the pivotal study also was conducted to evaluate the long-term safety of Vioxx.

Vioxx was generally well tolerated among pediatric and adolescent patients in the study. The most commonly reported adverse events in patients taking Vioxx over the 12-week period were upper abdominal pain, nasopharyngitis (viral infection of the upper respiratory passages), diarrhea, upper respiratory tract infection, abdominal pain, headache and rhinitis.
Vioxx available in tablet and strawberry-flavored liquid formulation for children
Vioxx offers the convenience and simplicity of once-daily dosing in both tablet and strawberry-flavored liquid (oral suspension) formulation. For adolescents 12 to 17 years of age, the recommended dose of Vioxx is 25 mg once daily. For children and adolescents two to 11 years of age, dosing is dependent upon weight: for children weighing 22-88 pounds, the recommended dose of Vioxx is 0.6 mg/kg to a maximum of 25 mg once daily and for those over 88 pounds, Vioxx 25 mg once daily is recommended. To improve dosing accuracy among young children, use of Vioxx 12.5 mg/5mL oral suspension is recommended.

Important information about Vioxx
People with allergic reactions, such as asthma, to aspirin or other arthritis medicines should not take Vioxx. In rare cases, serious stomach problems, such as bleeding, can occur without warning. Patients should inform their physicians if they have or have had liver or kidney disease, or angina (for example, chest, arm or jaw pain), a heart attack or a blocked artery in their heart. Vioxx cannot take the place of aspirin for the prevention of heart attack or stroke. Vioxx should not be used by women in late pregnancy.

Commonly reported side effects in clinical trials with Vioxx in adults have included upper-respiratory infections, diarrhea, nausea and high blood pressure.

Vioxx is approved in the U.S. for the relief of the signs and symptoms of osteoarthritis and adult rheumatoid arthritis, management of acute pain in adults, primary dysmenorrhea and acute treatment of migraine attacks with or without aura in adults. The safety and effectiveness of Vioxx have not been established for cluster headache, which is present in an older, predominantly male, population.

The recommended starting dose of Vioxx for the treatment of osteoarthritis is 12.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 25 mg once daily. For rheumatoid arthritis, the recommended dose is 25 mg once daily. The maximum recommended daily dose for osteoarthritis and rheumatoid arthritis is 25 mg once daily.

Vioxx 50 mg once daily is the recommended dose for acute pain and primary dysmenorrhea. Use of Vioxx for more than five days in management of pain has not been studied. Chronic use of Vioxx 50 mg is not recommended.

For the treatment of migraine attacks, the recommended starting dose is 25 mg once daily. Some patients may receive additional benefit with 50 mg as compared to 25 mg. The maximum recommended daily dose is 50 mg. The safety of treating more than five migraine attacks in any given month has not been established. Chronic daily use of Vioxx for the acute treatment of migraine is not recommended.


References:
· (1) IMS Health, National Prescription Audit (NPA) Plus(TM) and NPA Plus 7(TM). Based on total dispensed prescriptions for the period May 1999 through April 2004 and the weeks ending May 7 through May 21, 2004.
· (2) Lawrence, R. et al, "Estimates of the Prevalence of Arthritis and Selected Muculoskeletal Disorders in the United States" Arthritis & Rheumatism Vol. 41, No. 5, 1998:778-799.9556417


SOURCE: MERCK & CO., Inc.

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