Thursday March 18, 8:00 am Eastern Time
Company Press Release
SOURCE: Merck & Co., Inc.
In Multiple Studies, Merck's Investigational
COX-2 Specific Inhibitor Vioxx(TM)
Relieved Moderate to Severe Acute Pain; A
Single Dose of Vioxx Provided the Same Degree and Onset of Pain
Relief as High Doses of Widely Prescribed Medicines in Studies of
Menstrual and Dental-Surgery Pain
SAN ANTONIO, March 18 /PRNewswire/ -- Vioxx(TM) (rofecoxib), Merck & Co., Inc.'s (NYSE: MRK - news),
investigational COX-2 specific inhibitor, relieved moderate to severe acute pain to the same degree and in the same amount
of time as high doses of two leading traditional pain relief medicines. Results from new pain studies were presented today
at the annual meeting of the American Society of Clinical Pharmacology and Therapeutics.
In two studies of menstrual pain involving a total of 190 women, a single dose of Vioxx 50 mg was comparable to a single
dose of naproxen sodium 550 mg and superior to placebo over the first eight hours after dosing, the primary endpoint.
Moreover, in both studies, pain relief was sustained at 12 hours, the last time point measured. Vioxx also relieved pain
within one hour, the same time as naproxen sodium.
In addition, in a study of pain following the surgical removal of wisdom teeth, a single dose of Vioxx 50 mg provided
relief over 24 hours. In that study, patients were given either Vioxx 50 mg, ibuprofen 400 mg, or placebo.
''In both the menstrual and dental pain studies, a single dose of the COX-2 specific inhibitor, Vioxx, relieved moderate to
severe pain that was sustained throughout the entire duration of the studies,'' said clinical study investigator Donald R.
Mehlisch, M.D., D.D.S., Senior Clinical Advisor, SCIREX Corp., Austin, Texas.
Vioxx Provided Relief of Moderate to Severe Menstrual Pain
In the first of two studies on menstrual pain presented, 127 women were randomized to Vioxx 50 mg, Vioxx 25 mg,
naproxen sodium 550 mg or placebo. In the second study, 63 women were randomized to Vioxx 50 mg, naproxen sodium
550 mg or placebo. Vioxx, at either dose, was comparable to naproxen sodium and superior to placebo in relieving pain.
Women who were aged 18 and older and who had moderate or severe menstrual pain during a minimum of three or four of
the previous six menstrual cycles were included in the studies. The studies were randomized, double-blind and
placebo-controlled with crossover design. A crossover design is one in which each patient takes each of the study drugs
once at different times during the course of the study. Patients were observed for 12 hours after dosing.
Primary dysmenorrhea, or painful menstruation, is one of the most common gynecologic disorders, affecting more than 50
percent of menstruating women. The condition is characterized by moderate to severe menstrual pain when no other
pre-existing gynecologic conditions exist. The most common treatment prescribed for primary dysmenorrhea is naproxen
sodium, according to published prescription data (National Disease & Therapeutic Index, IMS, 1998).
In the studies, treatment with Vioxx was generally well tolerated. The most commonly reported side effects, occurring at a
similar rate across all treatment groups including placebo, were upper respiratory infection, diarrhea, nausea and headache.
Vioxx Provided Sustained Pain Relief Following Dental Surgery
In the dental pain study of 151 patients, a single 50 mg dose of Vioxx provided pain relief comparable to a single dose of
ibuprofen 400 mg and better than placebo over the first eight hours after dosing, the study's primary endpoint. Vioxx
relieved pain within 45 minutes, the same time as ibuprofen.
In the study, the single dose of Vioxx provided pain relief that was sustained over 24 hours.
The study was single-center, randomized, placebo-controlled, and double- blind. It included healthy patients aged 16 and
older who had dental surgery to remove two or more wisdom teeth, one of which was partially embedded in bone. As
operative anesthesia wore off, patients who developed moderate to severe self-assessed pain were administered single
doses of either Vioxx 50 mg (n=50), ibuprofen 400 mg (n=50), or placebo (n=51). Patients were evaluated for a total of
five visits on three different days.
In the study, treatment with Vioxx was generally well tolerated. The most commonly reported side effects, occurring at a
similar rate across all treatment groups including placebo, were upper respiratory infection, diarrhea, nausea and headache.
About Vioxx
Merck submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Vioxx on Nov. 23,
1998. The NDA is currently under review by the FDA for the treatment of the signs and symptoms of osteoarthritis, the
relief of pain, and the management of primary dysmenorrhea.
COX-2 specific inhibitors work by inhibiting the enzyme COX-2 without significantly inhibiting COX-1. COX-1 produces
prostaglandins that are believed to be responsible for maintaining important day-to-day normal body functions, including
the protection of the lining of the stomach. COX-2 is responsible for producing prostaglandins that are believed to be
primarily responsible for pain and inflammation.
Currently available medicines to treat pain, NSAIDs, inhibit both COX-1 and COX-2. COX-2 specific inhibitors, such as
Vioxx, are being studied to determine whether the apparent differences in how they work may result in fewer serious
gastrointestinal side effects than traditional NSAIDs.
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.
Vioxx(TM) is the Merck trademark for rofecoxib.
For more information, contact Media, Rebecca Higbee, 215-652-5654, or Chris Fanelle, 215-652-3203, or Investor,
Laura Jordan, 908-423-5185, all of Merck & Co.
SOURCE: Merck & Co., Inc. |
