ARCOXIA Relieved Pain from Acute Gouty Arthritis Comparable to Indomethacin in Patients with Either Moderate or Severe Pain, New Analysis Showed.

Business Editors/Health & Pharmaceutical Writers

VANCOUVER, British Columbia--(BUSINESS WIRE)--May 7, 2004

Results from a combined analysis of two studies of patients with acute gouty arthritis demonstrated that ARCOXIA(TM) (etoricoxib) 120 mg once daily relieved the pain of acute gouty arthritis as well as indomethacin (50 mg three times daily) both in patients with moderate pain and in patients with severe pain. ARCOXIA is Merck & Co. Inc.'s investigational medicine for arthritis and pain. Researchers will present results here today at the 23rd Annual Scientific Meeting of the American Pain Society.

"Acute gouty arthritis is one of the most excruciatingly painful arthritic diseases," said David Daikh, M.D., Ph.D., study investigator and assistant professor of medicine, University of California, San Francisco. "In this analysis, ARCOXIA 120 mg once daily provided effective relief for patients with moderate pain and for those with severe pain, and was comparable to indomethacin, the standard therapy for acute gouty arthritis for more than 30 years."

Study design

The analysis combined the results of two identically designed, published studies(1) that demonstrated comparable efficacy of ARCOXIA and indomethacin in acute gouty arthritis. The purpose of the combined analysis was to evaluate the response to ARCOXIA and indomethacin by analyzing the subgroups of patients with moderate or severe/extreme baseline pain.

In the studies, 339 patients with acute gouty arthritis were randomized to receive either ARCOXIA 120 mg once daily (n=178) or the non-selective non-steroidal anti-inflammatory drug (NSAID) indomethacin 50 mg three times daily (n=161).

The primary endpoint of the analysis was patient assessment of joint pain over the first four full days of treatment (Day 2 through 5). Secondary endpoints of the analysis over the entire seven-day treatment period included patient global assessment of response to treatment, investigator global assessment of response to treatment and joint tenderness.

Patients completed pain assessments at baseline and on each day of the study four hours after their daily dose of study medication. They were seen in the clinic for office visits on Days 1, 2, 5, 8 and 22 (14 days after the last dose of the study medication on Day 8).

ARCOXIA and indomethacin provided comparable efficacy, regardless of pain severity

In the analysis, the efficacy of ARCOXIA in treating pain over Days 2 through 5 was comparable to that seen with indomethacin in patients with moderate pain and in patients with severe/extreme pain.

On a scale of 0 (no pain) to 4 (extreme pain), patients with moderate pain treated with ARCOXIA reported a 1.14 unit decrease in their pain level from baseline, while those receiving indomethacin reported a 0.99 unit decrease in their pain level from baseline. Patients with severe/extreme pain treated with ARCOXIA reported a 2.00 unit decrease in their pain level from baseline, while those receiving indomethacin reported a 2.06 unit decrease in their pain level from baseline.

There was a significantly greater reduction (p less than 0.001) of baseline pain for patients with severe/extreme pain (ARCOXIA, -2.00; indomethacin, -2.06) vs. for patients with moderate pain (ARCOXIA, -1.14; indomethacin, -0.99).

In addition, ARCOXIA and indomethacin provided comparable efficacy in all secondary endpoints in both subgroups of patients (moderate or severe/extreme).

ARCOXIA was generally well tolerated

In each of the two individual studies, both ARCOXIA and indomethacin were generally well tolerated. The most common drug-related adverse events included dizziness (2.8 percent for ARCOXIA, 14.3 percent for indomethacin), hypertension (5.6 percent for ARCOXIA, 8.7 percent for indomethacin), diarrhea (2.8 percent for ARCOXIA, 4.3 percent for indomethacin), nausea (1.7 percent for ARCOXIA, 5.6 percent for indomethacin) and headache (1.1 percent for ARCOXIA, 6.2 percent for indomethacin).

About acute gouty arthritis

Acute gouty arthritis affects approximately 2.2 million people in the United States alone each year.(2) It is one of the most common forms of inflammatory joint disease in men over the age of 40.

Acute gouty arthritis is associated with intense pain and inflammation that can reach peak levels within a few hours and remain at that level for several days. Acute gout is characterized by painful joint inflammation caused by metabolic imbalances that result in the overproduction or under excretion of uric acid. This leads to the deposits of monosodium urate crystals in the joint fluid and joint lining, especially in the joints of the lower extremities such as feet, ankles and knees. The inflammation associated with gouty arthritis typically causes intense pain, swelling, tenderness and heat and redness of the joint tissue.

About ARCOXIA and Merck

The Food and Drug Administration currently is reviewing Merck's New Drug Application for ARCOXIA, which seeks indications for the treatment of osteoarthritis, rheumatoid arthritis, chronic low back pain, acute pain, dysmenorrhea (menstrual pain), acute gouty arthritis and ankylosing spondylitis. ARCOXIA has been launched in 44 countries worldwide in Europe, Latin American and the Asia-Pacific region.

Merck & Co., Inc. is a global research-driven pharmaceutical products company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures.

FORWARD-LOOKING STATEMENT: This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2003, and in our periodic reports on Form 10-Q and Form 8-K (if any) which Merck incorporates by reference.

(1) Schumacher HR, Boice JA, et al. Randomised double blind trial of etoricoxib and indomethacin in treatment of acute gouty arthritis. British Medical Journal. June 2002; 324:1488-92. Rubin et al. Efficacy and safety profile of treatment with etoricoxib 120 mg once daily compared to indomethacin three times daily in acute gout: A randomized controlled trial. Arthritis & Rheumatism. February 5, 2004; 50 (2): 598-606.

(2) National Center for Health Statistics: Collins JC: Prevalence of selected chronic conditions, United States, 1979 - 1981. Vital and Health Statistics, Series 10, No. 155. DHHS Pub. No. (PHS) 86-1583. Washington, DC, U.S. Government Printing Office, 1986.