Large Scale Community-Based Study Shows NSAID Offers No Additional Benefit to
  Muscle Relaxant in Treatment of Acute Pain and Muscle Spasm of the Back or
                                     Neck

    SAN FRANCISCO, Oct. 18 /PRNewswire/ -- More is not necessarily better when
it comes to treating acute muscle pain and spasm of the back or neck suggest
results from the first community-based trial to evaluate the benefits of
adding a non-steroidal anti inflammatory (NSAID) to treatment with a commonly
prescribed muscle relaxant. According to the study, the muscle relaxant
FLEXERIL(R) 5 mg (cyclobenzaprine HCl), taken three times a day, is as
effective alone as when taken in combination with ibuprofen at over-the-
counter (OTC) or prescription doses.
    More than 770 adult back and neck pain and muscle spasm sufferers at
multiple community-based sites throughout the United States completed the
randomized, multi-center, open-label one-week study, which compared thrice-
daily treatment with FLEXERIL 5 mg alone or in combination with ibuprofen at
over-the-counter (1,200 mg/day) or prescription doses (2,400 mg/day).
Researchers shared results of the trial today at the 2004 Scientific Assembly
of the American College of Emergency Physicians. A final report, including
full data on all endpoints, will be completed soon.
    "In clinical practice, acute muscle pain with spasm is often treated with
a non-steroidal anti-inflammatory drug (NSAID) alone or in combination with a
muscle relaxant," explained Martin Childers, D.O., Ph.D., Associate Professor,
Department of Physical Medicine and Rehabilitation, School of Medicine,
University of Missouri-Columbia. "The data from this study indicates that the
addition of ibuprofen offers no further pain relief compared to taking
FLEXERIL 5 mg alone."

    About the Study
    Men and women between 18 and 65 years of age with acute muscle pain with
spasm of the neck or back of up to 14 days participated in the seven-day study
conducted by more than 100 physicians. Patients self-reported pain intensity
and muscle spasm intensity at baseline and after 3 and 7 days of randomized
treatment of FLEXERIL 5 mg three-times-a-day alone or in combination therapy
with over-the-counter ibuprofen 400 mg three times a day (tid) or prescription
dose ibuprofen 800 mg tid.
    Results showed that all three treatments had statistically significant
improvements for both spasm and pain from baseline after three and seven days
of therapy. Additionally, the changes from baseline were significantly greater
after one week of therapy than after three days for all three treatments for
spasm and pain. This treatment duration finding was expected and consistent
with previous studies. There were no statistically significant differences
among the groups.
    The types of adverse events observed in this study were consistent with
the known safety profiles of these medications.

    About FLEXERIL 5 mg
    FLEXERIL 5 mg should be used for relief of painful muscle spasm along with
rest and physical therapy. It should only be used for short periods of time,
usually 2-3 weeks.
    FLEXERIL 5 mg is a prescription medicine and should not be taken by
patients who have had a recent heart attack or have heart disease. It should
not be used by people with an overactive thyroid or who are currently or have
recently used MAOIs.  Use of FLEXERIL 5 mg with MAOIs can result in serious
health complications.
    FLEXERIL 5 mg may enhance the effects of alcohol and other medicines that
work on the central nervous system. In clinical studies the most common side
effects were drowsiness, dry mouth, and fatigue. For more information about
FLEXERIL 5 mg, including full U.S. Prescribing Information, visit or call
1-888-440-7903.
    Previously published data demonstrates that the 5 mg and 10 mg strengths
of FLEXERIL are comparable in their ability to provide clinically significant
relief from the pain of acute musculoskeletal spasm of the back and neck,
although patients taking FLEXERIL 5 mg report significantly less drowsiness
than patients taking the 10 mg tablet.

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