VIOXX Relieved Acute Pain Following Bunion Surgery in New Placebo-Controlled Pilot Study

Business Wire, Sept 3, 2003

Business Editors/Health & Pharmaceutical Writers

PRAGUE, Czech Republic--(BUSINESS WIRE)--Sept. 3, 2003

Merck & Co., Inc.

One Dose Daily of Merck's Arthritis and Pain Medicine Provided

Sustained Pain Relief on Day One and over Five-Day Period

In a pilot study of a COX-2 selective inhibitor for the treatment of postoperative bunionectomy pain, VIOXX(R)(rofecoxib) 50 mg once daily provided significant pain relief over eight hours compared with placebo. VIOXX 50 mg also provided sustained pain relief compared to placebo over four additional days. Results of the pilot study were presented here today at the Pain in Europe IV Conference. A larger study with VIOXX in postoperative bunionectomy pain is underway.

VIOXX is Merck & Co., Inc.'s once-daily medicine approved for osteoarthritis, adult rheumatoid arthritis, management of acute pain in adults and primary dysmenorrhea. In addition to the data in postoperative bunionectomy pain, VIOXX has been shown to provide analgesic relief in the treatment of other acute pain conditions such as dental surgery pain and post-orthopedic surgical pain.

"In this pilot study, VIOXX relieved the severe pain associated with bunion surgery on various analgesic measurements in comparison to placebo," said lead study investigator Paul J. Desjardins, D.M.D., Ph.D., clinical professor at the University of Medicine and Dentistry of New Jersey, visiting professor at Tufts University and head of the Clinical Site Operations Department for SCIREX Corporation in Austin, Texas. "Bunions are a common foot deformity, which can cause severe pain. Surgery to realign the joint and correct the deformity can be very painful."

Study design and results

The double-blind, randomized pilot study enrolled patients who had undergone bunion surgery, which involved cutting the bone of the big toe and realigning the joint. Patients experiencing moderate or severe pain approximately 24 hours after surgery were randomized to VIOXX 50 mg once daily (n=27), the recommended dose for the management of acute pain in adults, or to placebo (n=26). Patients were allowed to take an additional narcotic pain reliever during the study if needed, but were encouraged to not do so in the first 90 minutes.

The primary endpoint of the study was total pain relief over the first eight hours after dosing as measured by TOPAR8(1). Other efficacy measurements assessed included the sum of pain intensity differences over eight hours (SPID8)(2), patients' global assessment of medication at eight hours, time to onset of pain relief and time to first use of additional pain relief medication. On days two to five, efficacy was measured by patients' global evaluation of medication at bedtime and the number of additional pain relief medication tablets used.

Results on day one showed:

-- Total pain relief over eight hours (primary endpoint): VIOXX

50 mg provided significant pain relief compared with placebo

as assessed by TOPAR8. The mean TOPAR8 score was 10.5 for

VIOXX compared to 4.0 for placebo (p=0.004).

-- Sum of pain intensity difference: VIOXX provided significant

pain relief compared to placebo as measured by SPID8. The mean

sum of pain intensity differences over eight hours was 4.0 for

VIOXX compared to 0.1 for placebo (p=0.004).

-- Patient assessment of study medication: VIOXX 50 mg provided

significant pain relief compared to placebo over eight hours

as measured by patients' satisfaction with study medication

(0-4 scale) (mean score was 1.54 for VIOXX and 0.72 for

placebo; p=0.020).

-- Onset of analgesia: Median time to onset, defined as the

median time to patients' confirmed perceptible pain relief,

was shorter for VIOXX 50 mg (35 minutes) than for placebo (> 8

hours) (p=0.058).

-- Time to use of additional medication: The median time until

patients used additional pain relief medication was

significantly longer for VIOXX (approximately four hours)

compared with placebo (approximately two hours) (p=0.010).

On days two to five:

-- Patient assessment of study medication: VIOXX provided

significant analgesic effect versus placebo as assessed by

patients' global evaluation scores (p=0.003).

The majority of patients (up to 67 percent) taking VIOXX rated

their study medication as good, very good or excellent each

day compared with fewer than one-third (up to 30 percent) of

patients taking placebo.

-- Use of additional medication tablets: On average, there was a

trend toward less use of additional pain relief medication, as

measured by tablets per day, for those taking VIOXX (average 2

tablets) compared with patients in the placebo group (average

3 tablets) (p=0.105).

VIOXX was generally well tolerated in the pilot study. The most common overall adverse events reported in the study were nausea, headache and vomiting.

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 liver or kidney disease, or a history of angina, 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.